Risk Management Evaluation Endosulfan

165.The institute for fire and disaster control Heyrothsberge in Germany tested six fluorine free alcohol resistant firefighting foams and one PFAS containing foam for their ability to extinguish fires of five different polar liquids. The authors conclude that there are fluorine-free foams available which show a similar performance compared with PFAS containing foams (see Keutel and Koch, 2016). 43

166.Products based on 6:2 fluorotelomers have been developed by fluorotelomer manufacturers with the aim to replace earlier products such as side-chain fluorinated polymers and phosphate diesters that were based on longer-chain fluorotelomer derivatives (Loi et al., 2013). For example, several 6:2 fluorotelomer-based side chain fluorinated polymers have been registered in the Inventory of Effective Food Contact Substance (FCS) Notifications of the United States Food and Drug Administration including e.g. products from Asahi or Daikin (Wang et al., 2013). However, according to the information submitted by IPEN, there is a lack of publicly available information on toxicity and POPs properties. 43

167.A global manufacturer in specialty chemicals, received in 2015 US Food and Drug Administration (FDA) food contact approval for an oil- and grease-resistance additive, which is PFOA-free and provides high levels of
oil-, grease- and water-resistance to paper and board. The additive is also compliant with the recommendations or use as a surface refining and coating agent in paper and board, which is intended for food contact applications. The additive is based on a cationic 6:2 fluorotelomer-based side-chain fluorinated polymer and provides a strong and long lasting barrier to both grease and water. According to the manufacturer, due to its performance properties and environmental profile the additive is considered particularly suitable for the use in both size press and wet-end applications to produce fast food boxes and wrappers, soup cube boxes, butter wrap and oil bottle labels. It can as well be used in the production of molded pulp plates and cups and in pet food packaging (AMR, 2015). 43

168.FDA currently does not allow long-chain fluorinated substances in food packaging applications. FDA removed the last legacy long-chain PFOA-related substances from 21 CFR 176.170 in 2016 (see 81 Fed. Reg. 5–8). Any 2015 FDA approvals for a resistance coating applied to paper and board would have been for a short-chain alternative, and would have been done through the Food Contact Notification (FCN) process. 43

169.At least one manufacturer from Norway has developed a fluorine-free alternative using a
high-density paper, which prevents the passage of grease (Swedish Chemicals Agency, 2015). The Norwegian paper producer Nordic Paper is using mechanical processes to produce, without using any persistent chemical, extra-dense paper that inhibits leakage of grease through the paper. 44

170.More information is available in Norden 2013, SFT 2007 and Nordic Ecolabelling 2014. Nordic Ecolabelling 2014 indicates that for impregnation and coating paper can be surface treated using starch, alginates, CMC (carboxylmethylcellulose), chromium compounds, fluoride chemicals or silicone. Organotin compounds are used as catalysts in the silicone coating of grease-proof paper and may migrate into food in contact with paper. Butyltin is specifically mentioned as catalyst in the paper. The Ecolabel contains requirements to prevent the presence of chromium, fluoride compounds, whereas solvent-based painting/coating agents, D4 and D5 and organotin catalysts may not be used in the silicone treatment. These substances may still be used elsewhere and thus be imported into Europe. 44

171.The German BfR (BundesinstitutfürRisikobewertung) maintains a database concerning recommendations on Food Contact Materials including fluorinated and non-fluorinated substances. 44

172.Industry associations noted that especially in the field of professional, technical and protective textiles and other advanced textiles (e.g. for fuel cell separators for e-mobility innovations), no alternatives meeting the high demand by legal requirements and by customers are currently available. However, it is admitted that those textile products that must only fulfil low-performance requirements (e.g. standard clothing, standard outdoor textiles), which were formerly treated with PFOA-related compounds, may be treated by C6-products or even fluorine-free alternatives (VTB SWT, 2016; Euratex, 2016). 44

173.Stakeholders state that protective textiles finished with the C6-chemistry need large amounts of C6-products for the initial finishing and repeated professional re-impregnation with further C6-products after each washing step in order to meet high safety standards; this will result in additional emissions of PFASs due to the larger amounts of used chemicals compared to the C8-chemistry (VTB SWT, 2016). In this context, it was mentioned that over the life-cycle technical textiles treated with 6:2 fluorotelomer-based finishes often exhibit 4-8 times more PFAS total emissions compared to the observed emissions using the C8-chemistry (Euratex, 2016). 44

174.The textile industry reported that the C8-chemistry is able to fulfill the high requirements related to repellency of dangerous liquids and dusts while having a minor detrimental effect on flame retardations. This preferable combination of the two effects cannot be obtained by C6-based products. Moreover, it was stated that technical protective textiles protect workers from being contaminated by liquids or dangerous substances (e.g. infectious liquids). Thus, serious health issues might occur in case of neglected re-impregnation, which is required due to a decrease in protection performance over time (VTB SWT, 2016), (TM, 2016). 45

175.According to I&P Europe, PFOA-related compounds were successfully replaced by
non-perfluorinated chemicals, chemicals with short (C3-C4) perfluorinated chains, telomers, and reformulations. However, a small number of relevant uses remain. PFOA-related compounds are considered necessary for the application of coating layers during manufacture of some remaining conventional photographic products (i.e. products in which the image formation is based on silver halide technology). They serve as surfactants, static control agents (important for preventing employee injury, operating equipment and product damage and fire and explosion hazards (I&P Europe, 2016b), dirt repellents during coating operations, friction control agents and provide adhesion control for coated layers and are considered unique, as they combine all these properties in one molecule without showing adverse effects on photographic performance (I&P Europe, 2016a). 45

176.An estimation of costs with regards to the replacement of the remaining relevant uses of PFOA-related substances in the photo and printing industry cannot be estimated. The formulas of imaging coatings are proprietary and differ from company to company and from product to product. Thus, each company will identify different costs when changing formulation compositions, which may take several years of effort with respect to research and development (not only the performance of substances is evaluated when developing alternatives, but also environmental, health and safety issues). Economic costs associated with substitution of PFOA-related substances concerning few remaining critical relevant uses in the imaging and photographic sector are considered prohibitive by the industry. The remaining critical uses are described as niche products in markets that I&P Europe members plan to diminish (I&P Europe, 2016a). 45

177.Non-PFOA-based alternatives appear to be available in the semiconductor industry for some applications, such as the uses as surfactants. However, some uses with respect to PFOA-related substances as a constituent material in process, chemical formulations for very specialized application steps (e.g. for the photo-lithographic applications) remain. In a study from 2010, it was found that for those companies using PFOA within their photo-lithographic applications derogations will be necessary in order to be able to continue production (van der Putte et al., 2010). According to representatives of the semiconductor industry, alternatives for some applications may not be available, and the industry requires a significant amount of time to identify, test, and qualify substitutes before they are introduced into commercial production. A specific time frame needed for transition is not indicated (see SIA, 2017). A time limited exemption could provide the time needed to enable to continue the transition to appropriate alternatives in semiconductor manufacturing processes. SEMI further states, that this exemption should take the form of an acceptable purpose (see SEMI, 2017). 45

178.Currently, the active ingredients registered in Brazil for producing bait to control leaf-cutting ants are sulfluramid, fipronil and chlorpyrifos. Chlorpyrifos as insect baits is no longer used in Brazil for control leaf cutting ants (UNEP/POPS/POPRC.12/INF/15/Rev.1). The effectiveness of these substances has been questioned; thus new alternatives are being studied in Brazil. According to the Brazilian Annex F information, sulfluramid cannot currently be efficiently replaced in Brazil by any other registered products commercialized for the same purpose (UNEP/POPS/POPRC.12/INF/15/Rev.1, UNEP/POPS/COP.7/INF/21). 45

179.According to Brazil, fenoxycarb, pyriproxyfen, diflubenzuron, teflubenzuron, silaneafone, thidiazuron, tefluron, prodrone, abamectin, methoprene, hydramethylnon, boric acid, some insecticides from the group of neonicotinoids, pyrethroids, Spinosyns, etc., had been tested for leaf-cutting ants, but they were not effective (UNEP/POPS/POPRC.12/INF/15/Rev.1). 46

180.According to the decision SC-6/7, Brazil undertake studies to obtain peer-reviewed information on the feasibility of using alternatives to PFOS, its salts, PFOSF and their related chemicals within an integrated pest management approach and to submitted to Secretariat. This study conclude that, based on technical feasibility, humans and environment effects, cost/effectiveness, availability and viability, that there are no alternatives to replace sulfluramid to control leaf-cutting ants (Information from Brazil, 2016). 46

181.Information on volumes is contained in UNEP/POPS/POPRC.12/INF/15/Rev.1. It was noted that there are some reports indicating that sulfluramid may degrade to PFOA and is in the list of precursors of PFOA (UNEP/POPS/POPRC.13/INF/6/Add.1). 46

182.The following paragraphs summarize information on alternatives from sections 2.3.1 to 2.3.3. 46

183.There is an increasing concern among authorities in Europe regarding risks for health and the environment exhibited by short-chain PFASs. These concerns are due to their persistence, high mobility in water and soil and potential toxic properties of these substances. Although some of the short-chain PFAS may not formally fulfil the current PBT-criteria under Europe’s REACH legislation, they are extremely persistent, very mobile in aquatic systems and in soil, and their increasing use may lead to a continuous exposure that could be of equal concern as bioaccumulation (Norway Comments on 2nd draft RME). Already now short-chain PFAS are ubiquitously present in the environment, even in the remote areas (see e.g. Zhao et al., 2012). 46

184.The higher solubility in water compared to long-chain PFASs with more hydrophobic alkyl chains also contributes to the fact that some short-chain PFASs, in particular short-chain PFCAs and PFSAs, do enter drinking water reservoirs faster and certain tend to accumulate in water-rich edible plant tissues like leaves and fruits. The presence in groundwater and drinking water might lead to a continuous exposure of organisms to certain short-chain PFASs, currently still at a relatively low level, but given the high persistence and the increasing use of these substances a temporal increase in environmental concentrations may be expected. This is even more valid as removal of short-chain PFASs from water cannot be performed effectively, not even with modern expensive technologies (e.g. using granular activated carbon or nano-filtration), due to their low adsorption potential (see German Environment Agency, 2016b). 46

185.It should be noted, that Germany is proposing to identify substances having such properties related to mobility and persistency as substances of very high concern under REACH in a similar manner as substances being very persistent and very bioaccumulative (see German Environment Agency, 2017). As described in chapter 2.3.2 these substances are considered alternatives to PFOA for several applications (e.g. textile sector, firefighting foams, paper and food packaging). Often, these short-chain alternatives are less effective and higher quantities are required. This data suggests that the replacement of PFOA, its salts and related compounds by short-chain fluorinated substances may be identified as a regrettable substitution. 47

186.In this context it should be noted that that pollution with short-chain PFAS is a heavy burden for the community/society. In Germany more than 450 ha of agricultural fields were polluted with PFAS most probably by intermixing paper sludge with compost. PFAS have been found in elevated concentrations in soil and groundwater. Short-chain PFAS are the main contaminants in this area. As a consequence, two drinking water wells were closed. Because shortchain PFAS can be taken up in the edible part of the plants and crops have been shown elevated levels of short-chain PFAS, before harvesting PFAS levels in crops need to be analysed in this area. Only crops not enriching PFAS can be cultivated and harvests showing elevated levels of short-chain PFAS cannot be consumed by humans or used as feed. A solution to purify the soil or to stop short-chain PFAS reaching the groundwater has not been found yet. Because of the large polluted area, excavation does not seem to be appropriate. The overall consequences for the inhabitants, the public and the farmers are immense. The costs for remediation and water purification and the supply for clean drinking water are high. The local water supply company has invested three million euros during the last two years for the supply of clean drinking water in the region. This investment is going to rise to 8 million euros until 2018 because a new purification plant based on activated carbon is being built and because operating costs will increase. Due to the properties of short-chain PFAS, the activated carbon has to be exchanged frequently, to avoid breakthrough of the chemicals. As a consequence the price for drinking water increased by 13.4% in this area in 2017. A further increase of the costs is possible (Germany Comments on 3rd draft RME). 47

187.Based on the analysis of alternatives, the following table summarizes for which sectors and specific uses alternatives to the use of PFOA, its salts and PFOA-related compounds are available or not. 47

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). 48

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). 48

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). 49

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). 49

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). 49

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). 49

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). 49

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 1st draft RME). 49

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 1st 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. 50

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 2nd draft RME). 50

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). 50

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). 50

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 1st 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 2nd draft RME). 51

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). 51

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). 51

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. 51

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 1st draft RME). 51

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 1st draft RME). 52

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. 52

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). 52

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. 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. 52

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). 53

210.IPEN considers that social costs associated with the elimination of PFOA are far outweighed by the health and environmental benefits (IPEN, 2016). 53

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). 53

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). 53

213.Several Parties and observers have submitted information on the access to information and public education: 53

214.PFOA has been measured in various media e.g. human blood and breast milk and in water, soil, sediment and biota including fish. Monitoring data from the database of the Environment Agency Austria (EAA) were provided (more details see Austria, 2016a). 54

215.In Canada, monitoring in environmental media and biota is used to evaluate the effectiveness of risk management controls and to measure progress towards eliminating PFOA in the Canadian environment. In addition, monitoring of PFOA is carried out as part of the Northern Contaminants Program which was established in 1991 in response to concerns about human exposure to elevated levels of contaminants in wildlife species that are important to the traditional diets of northern Indigenous people (NCP 2013). Over the period of 2007-2015, mean PFAS concentrations (wet weight) in liver were consistently comprised mostly of PFOS and ΣPFCAs (low levels of PFOA but mostly C9, C10 and C11 PFCAs). PFOS was consistently higher than ΣPFCAs, and it was consistently at ppm levels but at greater levels in southern Hudson Bay bears versus western Hudson Bay bears. There was no obvious increasing or decreasing trends for ΣPFCAs and PFOS for both. 54

216.PFASs including PFOA are part of the Danish monitoring of the aquatic environment. In the period from 2008-2013 PFASs have been included in monitoring of point sources as well as streams, lakes and marine areas. PFOS and PFOA are the most frequently detected PFASs in streams and one of the most frequently detected compounds in wastewater treatment plant effluents. Both in streams and effluents, they are detected in highest concentrations. (Denmark, 2016). 54

217.PFASs, including PFOA, are included in the Swedish Environmental Surveillance Program and the Swedish health related monitoring program (Sweden Comments on 2nd draft RME). PFOA and other perfluorinated compounds are also monitored in humans in Canada, for example under the Northern Contaminants Program, Canadian Health Measures Survey and Canadian Maternal-Infant Research on Environmental Chemicals. 54

218.PFAS including PFOA are monitored in human blood samples and urine from children and young adults. In the German Environmental Survey (GerES V) data are generated for the period from 2014-2017, PFAS is only one part of the study. The study also examines sources of pollutants such as indoor air and drinking water. 55

219.Many countries do not have the capacity to determine the products and wastes containing PFOA, its salts and PFOA-related compounds, as well as to identify their presence in different environmental matrices. This needs to be considered regarding the compliance with the obligations established by the Convention because such lack of capacity prevents to establish inventories, to identify relevant wastes and to carry out the respective monitoring. For this reason it is recommended to carry out pilot projects that allow demonstrating which measures should be taken to achieve effective compliance (Colombia Comments on 2nd draft RME). 55

220.According to the Annex F submission of IPEN many countries do not have the required infrastructure to adequately monitor production and use of PFOA (IPEN, 2016). 55

Synthesis of information 56

Summary of risk profile information 56

221.PFOA is persistent, bioaccumulative and toxic to animals, including humans. There is widespread occurrence of PFOA and a number of PFOA-related compounds in environmental compartments and in biota and humans. Therefore, it is concluded that 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). 56

222.It is difficult to predict confidently which specific uses and related releases contribute most to the risk, especially as there is such a diverse range of potential sources, and detailed information about most of them is lacking. Important potential sources of PFOA are considered to be the use of
side-chain fluorinated polymers in general, and specifically their use in the textile sector, and in manufacturing of fluoropolymers. Other important sources appear to be coatings and firefighting foam. Based on the available information, it is not possible to definitively identify specific uses of PFOA-related substances that will not contribute to PFOA emissions. 56

223. Annex E related submissions are compiled in a background document to the risk management evaluation (see UNEP/POPS/POPRC.13/INF/6). Other available data on production, uses and releases are compiled in the risk profile (UNEP/POPS/POPRC.12/11/Add.2). 56

Summary of risk management evaluation information 56

224.Restricting or prohibiting PFOA, its salts and PFOA-related compounds would positively impact human health and the environment by decreasing emissions and subsequently human and environmental exposures. 56

225.Several exemptions have been included in the risk management approach in the EU. Canada and Norway also include in their risk management approaches several exemptions, where some of the exemptions terminated at the end of 2016 (see Table ). 56

226.According to the information available for the analysis of alternatives, no technical and/or economically feasible alternatives currently exist for some specific uses in the semiconductor industry, but the industry indicates that alternatives will become available within the next years. Because of the low amounts used and the fact that emissions are expected to be low, a time limited exemption (until 4 July 2022) for the equipment used to manufacture semiconductors is given in the EU. Further, in the EU, an exemption without time limitation is given for photo-lithography processes for semiconductors or in etching processes for compound semiconductors. In Canada, semiconductors in manufactured items are exempted. In Norway an exemption for adhesives, foil or tape in semiconductors terminated by 2016. Based on industry information (see SEMI 2017), time limited or non-time limited exemptions should be considered for: (1) equipment containing PFOA residues in fluoropolymers and fluoroelastomers used to manufacture semiconductors, their replacement and spare parts and related infrastructure (i.e. facilities-related chemical, gas, and air distribution and control systems and chemical container systems for storage, conveyance, and transport of substances or mixtures); as well as for: (2) photo-lithography processes for semiconductors or in etching processes for compound semiconductors. 56

227.According to the information available for the analysis of alternatives for textiles, used for instance in the outdoor sector, alternatives are available, but, no technical and/or economically feasible alternatives exist for technical textiles with high performance requirements. This concerns use in textiles for the protection of workers from risks to their health and safety for which a time limited exemption (until 4 July 2023) is given in the EU. This is also the case for membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment. In Norway only textiles for consumer use are restricted, while textiles for professional use are not covered. The Canadian approach does not apply to manufactured items. Hence, import, use, sale and offer for sale of textiles containing PFOA, its salts or PFOA-related compounds are not restricted in Canada. Time limited exemptions should be considered under the Stockholm Convention for technical textiles with high performance requirements in particular for: (1) textiles for oil and water repellency or in application for the protection from dangerous liquids for the protection of workers from risks to their health and safety; and could be considered for: (2) membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment. For the latter, additional information to clarify the scope of the applications, used amounts, availability of alternatives and socio-economic aspects is needed to allow for an exemption. 57

228.The printing inks industry announced the need to use the substances until 2020 because these inks are especially designed for certain professional printers. This use only continues in printers that are no longer manufactured, and therefore a phase-out is already underway. For latex printing inks a time limited exemption (until 4 July 2022) is given in the EU. Canada had an exemption for water-based inks until 2016. The Norwegian risk management approach applies only to consumer products and does not restrict PFOA use in inks for professional printers. Depending on when obligations under the Stockholm Convention for PFOA, its salts and related compounds would possibly enter into force, an exemption may not be necessary for latex printing inks. 57

229.Production of short-chain fluorinated alternatives includes production of an unavoidable fraction of PFOA and PFOA-related substances that can be addressed by establishing appropriate concentration limits in manufacturing. The set of thresholds in the EU restriction is based on information from industry and takes into account the currently unavoidable fraction of PFOA and PFOA-related substances during production of C6 fluorotelomer alternatives. One option is for these substances to be re-processed as closed system site-limited isolated intermediates into production of short-chain fluorinated substances. The Stockholm Convention states that “Given that no significant quantities of the chemical are expected to reach humans and the environment during the production and use of a closed-system site-limited intermediate, a Party, upon notification to the Secretariat, may allow the production and use of quantities of a chemical listed in this Annex as a closed-system
site-limited intermediate that is chemically transformed in the manufacture of other chemicals that, taking into consideration the criteria in paragraph 1 of Annex D, do not exhibit the characteristics of persistent organic pollutants.” Neither Norway nor Canada or the EU has specific exemptions on the production of short-chain fluorinated alternatives in place. Therefore, an exemption for closed-system site-limited intermediates is not needed for substances listed under Annex A or B to the Stockholm Convention to allow such re-processing. For transported isolated intermediates an exemption without time limit is foreseen in the EU restriction according to its paragraph 4(c) provided that specific conditions are met (European Commission, 2017). An exemption could be considered under the Stockholm Convention for transported isolated intermediates in order to enable reprocessing in another site than the production site. The conditions could be similar to what is established under the EU restriction (see para 87). Additional information to clarify the quantities, extent of transport and risks, use is needed to allow for an exemption. 57

230.No alternative to PFOB as a processing aid has been found for pharmaceutical product manufacturing. PFOB is produced from PFOI which results from the production of
6:2 fluorotelomer-based substances. The production of PFOI takes place at one single site in Japan and is then transported to another site in Japan for use as intermediate in the production of PFOB. Afterwards, PFOB is transported to two sites in the US and Sweden to produce relevant pharmaceutical products. No related exemptions are proposed in the EU, Norway or Canada at the moment. In the SAICM context, environmentally persistent pharmaceutical pollutants have been adopted as an emerging policy issue, while recognizing that pharmaceuticals have major benefits for human health and animal welfare. According to information provided, the current production process starting from PFOI is considered the only reasonable way to produce PFOB. Furthermore, if an alternative to PFOB was to be found, the development process to incorporate it into the pharmaceutical products typically would require ten years to complete the three phases of human trials and the regulatory review process. 58

231.Digital imaging will replace the need for PFOA in photo-imaging and the transition is occurring rapidly. PFOA use in photo-imaging has been reduced by more than 95% worldwide since 2000 (I&P Europe). Further reduction in use of these substances is anticipated as the transition continues towards digital imaging. According to the analysis of alternatives, a small number of relevant uses remain in the photo-imaging sector. Within the EU restriction an exemption is given for photographic coatings applied to films, papers or printing plates without time limitation. The specific exemptions for this use in Norway and Canada expired in 2016, however, the Norwegian risk management approach only applies to consumer products and in Canada the import, use, sale and offer for sale of photo media coatings applied to films, papers or printing plates containing PFOA, its salts or PFOA-related compounds are not restricted. A time limited exemption should be considered under the Stockholm Convention for photographic coatings applied to films. At POPRC-13, industry provided information that time limited exemptions for paper and printing are no longer needed. It was also noted that for developing countries, such information was lacking. 58

232.One company applying coating for smartphone manufacturers requested, during the public EU consultation, an exemption of 3 years for pulsed plasma nano-coating for the transition to an alternative C6 chemical. For plasma nano-coating a time limited exemption (until 4 July 2023) is given in the EU. Norway and Canada have no specific exemptions on nano-coating in place. In Canada, the import, use, sale and offer for sale of coatings applied smartphones (or electronic equipment) containing PFOA, its salts or PFOA-related compounds are not restricted. Only one company asked for an exemption for a short period of time. 58

233.PFOA use in firefighting foams raises concerns because it is a dispersive, direct release to the environment. Alternatives to all uses of PFOA in firefighting foams exist and include fluorine-free solutions as well as fluorosurfactants with C6-fluorotelomers. Within the EU restriction, a limited exemption is given in order to provide an exemption for foams already placed on market. In addition, Canada provides exemptions for PFOA containing AFFFs used in firefighting application. The risk management approach in Norway does not apply, since it concerns consumer products and AFFFs are for professional use only. A time limited exemption for foams that already installed or placed on the market (as implemented for PFOS in the EU POPs Regulation) are covered under note (ii) and can be continued used in accordance with that provision. Use of existing foams should be avoided and existing foams should be replaced by sustainable alternatives in a short time frame to prevent further pollution. For training purposes, foams containing PFAS, including their fluorinated alternatives, must not be used. Suitable alternatives exist for training purposes. 58

234.Norway has an exemption in place for medical devices (no time limit). Within the EU restriction, a time limited exemption (until 7 July 2032) is given for medical devices other than for certain implantable medical devices within the scope of Directive 93/42/EEC. For the production of implantable medical devices an exemption without time limitation is given. The import, use, sale and offer for sale of medical devices containing PFOA, its salts or PFOA-related compounds are not restricted in Canada. According to the information submitted by IPEN, possible exemptions for these uses could be considered but consultation with health professionals using these medical devices should be considered. An exemption (with or without time limit) for: (1) use for medical devices; and (2) production of implantable medical devices under the Stockholm Convention, should therefore be considered. 59

235.Information on alternatives for the treatment of paper and cardboard used in food packaging indicates that appropriate alternatives are available. In the Norwegian risk management approach, food packaging and food contact materials are exempted. The import, use, sale and offer for sale of food packaging containing PFOA, its salts or PFOA-related compounds are not restricted in Canada. In the EU restriction, there are no exemptions for food packaging materials in place. Since appropriate alternatives are available, an exemption under the Stockholm Convention is not considered necessary. 59

236.According to the Canadian automotive industry, information automotive service and replacement parts might still contain PFOA. These parts are needed to ensure availability of original equipment and spare parts to satisfy customer demand. Therefore, specific exemptions are proposed by industry for automotive service and replacement parts. These parts represent a small percentage of PFOA use and will decrease naturally over time as the vehicle fleet turns-over. In Canada, the
PFOA-related risk management measures do not impact the use of automotive service and replacement parts as all manufactured items containing PFOA are currently addressed for the sector (see CVMA 2017). No related exemptions are given in the EU. In Norway the prohibitions shall not apply to spare parts for consumer products made available for sale prior to 1 June 2014. An exemption for automotive service and replacement parts could be considered under the Stockholm Convention; however, specification on relevant automotive service and replacement parts as well as sound justification why an exemption would be required, though in existing risk management approaches such an exemption was not considered necessary. 59

237.Due to increasing concerns about risks related to short-chain fluorinated alternatives (see paras 179 to 181), it remains unclear whether the replacement of PFOA, its salts and related compounds by
short-chain fluorinated substances may cause adverse effects possibly comparable to those of the replaced substances. Hence, it remains unclear whether the replacement of PFOA, its salts and related compounds by short-chain fluorinated substances will not be identified as a regrettable substitution. Scientists have warned against the replacement with other fluorinated alternatives in order to avoid long-term harm to human health and the environment (POPRC Alternatives Guidance, Blum et al., 2015). 59

238.Restricting or prohibiting PFOA, its salts and related compounds would positively impact human health and the environment including biota by decreasing emissions and subsequently reducing human and environmental exposure. Further, restricting or prohibiting PFOA would provide benefits for agriculture by decreasing emissions and subsequently adverse effects on agricultural crops. 60

239.When assessing the human health and the environmental impacts of restricting PFOA and PFOA-related compounds, it is crucial to take into account the specific concerns of PFOA as a POP substance. The magnitude and extent of the risks of PFOA and PFOA-related compounds cannot be quantified, but global action is warranted. Therefore, the risk management of these substances is driven by scientific data and precautionary action to avoid further potentially severe and irreversible impacts resulting from continued emissions. 60

240.Based on the analysis of their characteristics, some of the available alternatives are expected to pose lower health risks than PFOA and PFOA-related compounds. The EU restriction is expected to result in a net benefit to society in terms of human health impacts. While no quantitative analysis of benefits has been conducted in the Canadian regulatory risk management process, an improvement in environmental quality is expected from controlling these substances. The EU and the Canadian risk management approaches are considered to have moderate cost impacts because the market is already replacing PFOA and PFOA-related substances and because the risk management approaches provide time-limited exemptions and ongoing permitted uses for certain applications where the development of alternatives is underway or where there are currently no known alternatives. The same can be expected for the Norwegian risk management approach. A global restriction or prohibition under the Stockholm Convention is therefore expected to result in a net benefit to society in terms of human health impacts. 60

241.Cost competitive alternatives to PFOA that do not exhibit POPs characteristics have already been implemented in many countries. This indicates economic and technical feasibility of the alternatives. The economic aspects of substituting alternatives for PFOA include the (non-quantifiable) savings made on health and environmental costs resulting from decreased exposure. 60

242.Restricting or prohibiting PFOA, its salts and PFOA-related compounds would reduce costs by decreasing contamination of surface water, groundwater and soil, and would thus reduce costs for the identification and remediation of contaminated sites. The remediation costs are mainly related to the treatment of ground/drinking water and the excavation and disposal of contaminated soil. The data available indicate that there are considerable costs related to the remediation of PFAS including PFOA and PFOA-related compounds. 60

243.Decision POPRC-6/2 on PFOS outlines a series of risk reduction measures in a short-term, medium-term and long-term framework. The POPRC reaffirms the Stockholm Convention’s need to use best available techniques and best environmental practice destruction technologies for wastes. In cases where destruction technologies are not available, safe storage has to be ensured. 60

Suggested risk management measures 60

244.The Committee recommends time limited specific exemptions for uses of PFOA, its salts and PFOA-related compounds where sufficient information was provided as indicated in the concluding statement section. 60

Concluding statement 61

245.The Committee decides, in accordance with paragraph 9 of Article 8 of the Convention, to recommend to the Conference of the Parties that it consider listing pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in Annex A or B to the Convention with specific exemptions for the following: 61

246.Parties and observers, including the relevant industries, are invited to provide, information that would assist the possible defining by the Committee of specific exemptions for production and use of PFOA, its salts and PFOA-related compounds in particular in the following applications: 61

247.Furthermore, Parties and observers are invited to provide information that would assist the further evaluation by the Committee of pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in relation to its unintentional formation and release, in particular from primary aluminum production and from incomplete combustion. 62