Risk Management Evaluation Endosulfan

Summary of information on impacts on society of implementing possible control measures

Health, including public, environmental and occupational health

188.There is widespread occurrence of PFOA and a number of PFOA-related compounds in environmental compartments and in biota and humans. PFOA, its salts and related compounds that degrade to PFOA are likely, as a result of their long-range environmental transport, to lead to significant adverse human health and/or environmental effects such that global action is warranted (UNEP/POPS/POPRC.12/11/Add.2). Therefore, prohibiting or restricting PFOA, its salts and related compounds would positively impact human health and the environment by decreasing emissions and subsequently human and environmental exposure (see e.g. Norway, 2016; ECHA, 2015a, 2015c).

189.When assessing the human health and the environmental impacts of restricting PFOA and PFOA-related substances, it is crucial to take into account the specific concerns of these substances as PBT substances. These concerns are particularly related to the potential of PFOA to persist in the environment, which means that it is not (or only to a small extent) removed from the environment. Even if the emissions of PFOA and PFOA-related substances will cease, it will not result in an immediate reduction of environmental concentrations. In addition to its persistence, PFOA is mobile in the environment and has the potential to be distributed over long distances, e.g. via long range atmospheric transport. As a consequence, PFOA is present in the environment on a global scale, also in remote areas where PFOA emissions are negligible. Continuous use and emissions may lead to rising concentrations in the environment and to long-term, large-scale environmental and human exposure to PFOA. In combination with the potential of PFOA to accumulate in living organisms as well as its toxicological properties, continuous use and emissions of PFOA and PFOA-related substances may lead to adverse effects on human health and the environment arising from long-term exposure. These effects will be very difficult to reverse, once they have occurred. The magnitude and extent of the risks of PFOA and PFOA-related substances as POPs remain uncertain. Therefore, the risk management of these substances is driven by scientific data and precautionary action to avoid potentially severe and irreversible impacts resulting from continued emissions. This is evident even though the full physical impacts on human health and the environment of reducing the emissions of PFOA and PFOA-related substances cannot be quantified (ECHA, 2015a).

190.The EU restriction of PFOA and PFOA-related substances will require industry to phase out respective compounds in nearly all applications and sectors, eliminating all significant emission sources (apart from releases originating from the existing stock and exempted uses of PFOA and PFOA-related substances) (ECHA, 2015a). In the background document to the EU proposal for a restriction it is stated that there are considerably less data available on the toxicological properties of the most suitable alternatives than there are on PFOA. However, based on the analysis of alternatives they are expected to pose lower health risks than PFOA and PFOA-related substances. The restriction is therefore expected to result in a net benefit to society in terms of human health impacts (ECHA, 2015a).

191.Canada prohibits PFOA and long-chain PFCAs with certain exemptions to allow on-going and time-limited uses of these substances where technically or economically feasible alternatives do not exist or to allow sufficient time for the transition to alternatives to occur (see Canada, 2016c). While no quantitative analysis of benefits has been conducted, the amendments will protect the environment by prohibiting the manufacture, use, sale, offer for sale or import of PFOA and long-chain PFCAs. An improvement in environmental quality is expected from controlling these substances (Canada, 2016c).

192.Australia expects positive impacts from control measures related to avoided contamination of surface water, groundwater and drinking water and subsequently reducing the potential for human exposure (Australia, 2016).

193.Regarding professional, technical and protective textiles which must meet durable repellency performance standards, representatives from the textile industry state that, in view of the already made big progress of avoiding emissions, further restriction would seriously endanger the public health, environmental and occupational health by a ban of professional, technical and protective textiles (see VTB SWT, 2016 and TM, 2016).

194.According to representatives of the European photo industry, control measures implemented by the photo-imaging industry, including reformulation and product discontinuance, have reduced the use of PFOA-related compounds worldwide by more than 95%. The emissions from the small number of ongoing uses by the photo-imaging industry have been assessed by a number of competent authorities in the EU, including ECHA, and determined not to pose a relevant risk to the environment or human health (I&P Europe, 2016a). PFOA emissions from photographic applications and from the semiconductor industry appear to be less than 100 kg/year for the whole EU (and therefore lower risks in relative terms) (ECHA 2015c).

195.According to SIA, the total amount of PFOA and its related substances in semiconductor photolithography formulations sold in North America in 2015 was 720 kg. According to information provided by SEMI, the fluoropolymers incorporated into all semiconductor manufacturing equipment produced over the course of the last five years (2011-2015 data) at global level remain a marginal source of PFOA, estimated to be no more than 120 kg/year. Also, the fluoropolymer materials incorporated into facilities-related chemical, gas, and air distribution and control systems for semiconductor manufacturing (related infrastructure) are a marginal source of PFOA, estimated to be no more than 25 kg/year (SEMI Comments on 1^st draft RME).

Agriculture, aquaculture and forestry

196.PFOA is present in sewage sludge that is applied to agricultural land in certain countries depending on national legislation. Several agricultural crops showed species-dependent adverse effects (e.g. root growth and necrosis) mediated by PFOA (see UNEP/POPS/POPRC.12/11/Add.2 referring to Li, 2009 and Stahl et al., 2009). Crops grown in sewage treatment plant solid-amended soil take up PFOA alternatives such as PFBA and PFPeA (Blaine et al., 2013). PFBA, PFHxA, PFHpA, PFOA, and perfluorononanoic acid (PFNA) are translocated into plants (Bizkarguenaga et al., 2016; Krippner et al., 2014). PFOA and PFBA are also found in pine needles along ski tracks (Chropenova et al., 2016). In Australia, the legacy use of PFOA-containing AFFFs has affected some agricultural activities (see section 2.2.3). The use of sludge from any waste water treatment plant contaminates agricultural fields with PFASs, among them PFOA and related substances (Germany Comments on 1^st draft RME). In Germany, the (illegal) disposal of waste/sludge to agricultural fields has caused contamination of soil, ground and drinking water, agricultural crops and human exposure with severe consequences including loss of income for farmers (see section 2.2.2). Therefore, restricting PFOA, its salts and PFOA-related compounds would have benefits for agriculture.

Biota (biodiversity)

197.There is widespread occurrence of PFOA and a number of PFOA-related compounds in environmental compartments and in biota and humans. PFOA, its salts and related compounds that degrade to PFOA are likely, as a result of their long-range environmental transport, to lead to significant adverse human health and/or environmental effects (UNEP/POPS/POPRC.12/11/Add.2). Restricting PFOA, its salts and PFOA-related compounds would positively impact on biota by decreasing emissions and subsequently exposure of biota. This would have a flow on benefit for indigenous communities highly reliant on native species in their diet (IPEN Comments on 2^nd draft RME).

Economic aspects

198.Cost competitive alternatives to PFOA that do not exhibit POPs characteristics, such as fluorine-free alternatives used in firefighting foams or paper and food packaging, have already been implemented in many countries. This indicates economic feasibility of several alternatives. The economic aspects of substituting alternatives for PFOA include the savings made on health and environmental costs resulting from exposure to PFOA (IPEN, 2016).

199.In the EU, the use of PFOA and PFOA-related substances has contributed to the contamination of (drinking) water and soil with corresponding high costs of remediation. Most of the contamination has been caused by the use of PFAS (including PFOA and PFOA-related substances) in firefighting foams in fire events and training exercises. The remediation costs are mainly related to the treatment of ground/drinking water and the excavation and disposal of contaminated soil. The severity and extent of the damage caused and the related costs entailed difference between the cases reported. In some cases the total remediation cost is not known yet or not reported. Where costs are reported, they are very case specific often covering other PFAS as well, which makes it very difficult to derive a robust general estimate of remediation cost per kg PFOA and PFOA-related substances. However, the data available indicate that there are considerable costs related to the remediation of PFAS including PFOA and PFOA-related substances (ECHA, 2015a; specific cost figures see Table A.F.1-1 in ECHA, 2015a).

200.Environmental contamination with PFOA and PFOA-related compounds is also related to industrial activities according to examples such as from the US and the Netherlands (Norway Comments on 1^st draft RME). Norway refers to ongoing remediation of PFAS contaminated soil due to use of AFFFs at airports and fire training areas (Norway, 2016). In Australia, the stigma of being in a contaminated environment due to the legacy use of PFOA-containing AFFFs has led to decreasing property and business values and the loss of income for some land and business owners (see section 2.2.2). PFAS compounds are found in Danish groundwater at several locations in Denmark. PFAS are present near specific industries or activities, primarily fire drill sites. At some fire drill sites the PFOA concentration was exceeding the German limit value for drinking water for PFOA by approximately a factor of 10 and initiated the work establishing the Danish sum criterion drinking water limit value for 12 perfluorinated substances. It should also be noted that other PFAS compounds were also found at these sites (Danish EPA, 2014). High levels of PFAS (including PFOS and PFOA) have been found in groundwater in Sweden, especially in connection with the firefighting training sites and in areas where fires have been extinguished. In some cases, the concentrations of PFASs have been exceeded the action level of the National Food Agency in Sweden. As a consequence, wells and water utilities have had to introduce new treatment steps or switch to a non-contaminated water source (Swedish Chemicals Agency, 2016a). Identification and management of contaminated sites and groundwater can cause significant costs which will be reduced in the future if PFOA and PFOA-related compounds will be restricted. Finally, it should also be noted that these examples all come from developed countries with high capacity for prevention and remediation. In developing countries or countries in transition such actions would either need external funding and expertise or would not be conducted at all, leading to unacceptable harm to health and the environment (IPEN Comments on 2^nd draft RME).

201.A benchmark study using cost-effectiveness analysis to assess the proportionality of measures to control PFOA (and other substances) looks at the cost-effectiveness estimates for regulatory measures that have been applied or considered for PFOA. Although the search and assessment presented in the study has an explicit global scope and all available studies, reports, and publications that could be found online were included, there may be a slight European oversampling “bias” due to the authors’ domicile and language coverage. The available evidence suggests that measures costing less than 1,000 €/kg substance use or emission reduction will usually not be rejected for reasons of disproportionate costs, whereas for measures with costs above 50,000 €/kg substance such a rejection is likely. The mean estimated unit costs for substitution, emission control and remediation costs for PFOA are 1,580 €/kg (range 28 to 3,281) (see Oosterhuis et al., 2017).

202.The regulatory PFOA risk management approaches in Canada, the EU and Norway are not expected to lead to wider economic impacts, because the market is already replacing PFOA and PFOA-related substances. This is reflected by the estimated moderate compliance cost (ECHA, 2015a; Canada 2016c).

203.A technical and economic assessment has not been made to establish whether countries such as those in Latin America and the Caribbean or in Africa have the capacity to comply with obligations arising from including PFOA, its salts and PFOA-related compounds in any of the Annexes to the Convention, as well as the financial resources to develop inventories, carry out monitoring, and eliminate the substances or wastes containing them.

204.PFOA, its salts and PFOA-related compounds are used in some semiconductor production processes. Although replacement of the chemical by alternatives is ongoing, the functions of the alternatives are still inadequate and it is uncertain that the replacement would be finished by 2019. If they fail in replacement, semiconductor supply would decrease, and that may cast a large negative impact to IT development in the world (Japan, 2016). According to representatives of the semiconductor industry, without an exemption, the cost-effectiveness of the restriction would be disproportionate for the semiconductor manufacturing equipment industry (SEMI Comments on 1^st draft RME).

205.Norway states that the continued use of PFOA and PFOA-related compounds in textiles causes high socio-economic costs due to the PBT properties of the substances. Norway’s experience is that fewer textiles for consumers contain PFOA, and in the remaining textiles, the PFOA concentration has decreased (Norway Comments on 1^st draft RME).

206.The photo-imaging industry has been very successful at developing alternatives for most uses of PFOA-related compounds, eliminating more than 95% of the worldwide use since 2000. However, the industry claims that the surfactant and static control properties of PFOA-related compounds are important for the application of coating layers during manufacture of some remaining traditional film products (i.e. products in which the image formation is based on silver halide technology). The industry cannot estimate the cost of replacing this use of PFOA-related compounds, but notes that these are niche products in markets that will diminish (I&P Europe, 2016a). It is clear that digital imaging will replace the need for PFOA in this use and the transition is occurring rapidly.

207.FluoroCouncil member companies have invested significantly into the development of alternative polymerization aids and short-chain products and emission control technologies. Another cost to be recognized is the economic and human health cost of completely ceasing production of certain PFOA-related chemicals used in pharmaceuticals and other highly specialized applications. It should be noted that the environmental releases for these applications can be well controlled (FluoroCouncil, 2016a).

Movement towards sustainable development

208.Elimination of PFOA is consistent with sustainable development plans that seek to reduce emissions of toxic chemicals and several of the in 2015 globally adopted sustainable development goals. The SAICM makes the essential link between chemical safety and sustainable development. The Overarching Policy Strategy of SAICM aims to promote, by 2020, that chemicals or chemical uses that pose an unreasonable and otherwise unmanageable risk to human health and the environment based on a sciencebased risk assessment and taking into account the costs and benefits as well as the availability of safer substitutes and their efficacy, are no longer produced or used for such uses.²⁸ The Global Plan of Action of SAICM contains guidance on measures to support risk reduction that include prioritizing safe and effective alternatives for persistent, bioaccumulative, and toxic substances. In order to globally collaborate in gathering and exchanging information on perfluorinated chemicals and to support the transition to safer alternatives, a Global PFC group and a web-portal has been developed within SAICM.²⁹

209.Industry representatives of the professional, technical and protective textile sector invite other Parties to join R&D projects in the technical textile sectoron appropriate alternatives (more details see VTB SWT, 2016 and TM, 2016).

Social costs

210.IPEN considers that social costs associated with the elimination of PFOA are far outweighed by the health and environmental benefits (IPEN, 2016).

211.The restriction in the EU is not expected to have major effects on employment because, for the vast majority of uses, alternatives that are implementable with a reasonable cost are available. In addition, as imported articles and mixtures will also be covered by the restriction, relocation of production facilities to outside the EU is not a likely response by the industry concerned. Hence, it is not expected that there will be a significant loss (or gain) in employment in the EU due to the closing down and/or relocation of business activities (ECHA, 2015a).

212.Regarding the professional, technical and protective textile sector, industry considers that a total production ban by listing the substance under Annex A would result in negative effects on employment in the professional, technical and protective textile industry in Europe (see VTB SWT, 2016 and EURATEX, 2016).