Risk Management Evaluation Endosulfan

Identification of possible control measures

42.The control measure may be achieved in different ways under the Convention:

1. 
   PFOA, its salts and PFOA-related compounds may be listed in Annex A, with or without specific exemptions accompanied with a specific part of Annex A that details specific actions; or
   
2. 
   PFOA, its salts and PFOA-related compounds may be listed in Annex B, with acceptable purposes/specific exemptions accompanied with a specific part of Annex B that details specific actions; and/or
   
3. 
   PFOA may be listed in Annex C as an unintentional persistent organic pollutnat to capture potential formation and unintentional release from anthropogenic sources.
   

43.Possible control measures may include: (1) prohibition of production, use, import and export; (2) restriction of production, use, import and export; (3) control of discharges or emissions; (4) replacement of the chemicals by alternatives; (5) clean-up of contaminated sites; (6) environmentally sound management of obsolete stockpiles; (7) prohibition of reuse and recycling of wastes or stockpiles; (8) establishment of exposure limits in the workplace; and (9) establishment of thresholds or maximum residue limits in water, soil, sediment or food.

44.PFOA occurs as unintentional impurity in manufacturing of fluoro chemicals. However, unintentional generation from manufacturing can be addressed by establishing appropriate concentration limits in the Annex A or B recommendation for PFOA, its salts and PFOA-related compounds in manufacturing of alternatives.

Efficacy and efficiency of possible control measures in meeting risk reduction goals

45.According to the information submitted by IPEN, the most cost-effective and practicable control measure for PFOA and PFOA-related compounds is the prohibition of all production, use, import and export, which is particularly relevant in developing and transition countries that lack adequate regulatory and enforcement infrastructure. According to the information submitted by IPEN, this would be best accomplished by listing PFOA, its salts and PFOA-related compound in Annex A to the Stockholm Convention with no exemptions. Measures under Article 6 would address the
clean-up of contaminated sites such as at or near manufacturing facilities, airports, military bases and other sources, and environmentally sound management of stockpiles and wastes (IPEN Comments on 1^st draft risk RME).

46.Information received from stakeholders in the EU regulatory process indicates that exemptions for use where alternatives are not economically and/or technically feasible are required (ECHA, 2014a, 2015a).

47.The ECHA Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) considered that the restriction on PFOA, its salts and PFOA-related substances is the most appropriate EU-wide measure to address the identified risks. The EU restriction was adjusted to the occurrence in concentrations equal to or greater than 25 ppb of PFOA including its salts or 1000 ppb of one or a combination of PFOA-related substances. These limit values reflect the possible presence of unavoidable impurities and unintended contaminants, and take account of the capabilities of analytical methods (see European Commission, 2017). Details on modifications proposed by the scientific committees within the EU are documented in ECHA, 2015c.

48.In the process of developing the regulatory risk management approaches in Canada, Norway and the EU related to PFOA, its salts and PFOA-related compounds, technical and socio-economic information has been considered as a decision basis to allow for general or specific exemptions. As a consequence the exemptions in existing regulatory risk management approaches may give an indication for the identification of uses for which, there may not be accessible chemical and/or

non-chemical alternatives in a country, based on technical and socio-economic considerations.

49.Currently, controlled incineration with high temperatures of 850°C or higher is usually carried out in waste incinerators in developed countries. High temperature incineration (e.g., at 1000°C) is effective to destroy PFOA and to prevent the formation of PFOA from the thermolysis of highly fluorinated polymers (see Taylor, 2009, Taylor et al. 2014 and Yamada et al., 2005). It is currently unclear to what extent formation of PFOA may occur in municipal waste incinerators where (1) flue gases may reach temperatures of 850°C or greater and may result in different degradation products (García et al., 2007); (2) other substances coexist and may interfere with the thermolysis of fluoropolymers (e.g., thermolysis of PTFE is inhibited by a hydrogen or chlorine atmosphere in contrast to steam, oxygen or sulfur dioxide, which accelerate decomposition; Simon and Kaminsky, 1998); and (3) technologies such as activated carbon injection (ACI) coupled with baghouse filtration (BF) may be installed to remove dioxin or mercury and may also trap PFCAs (EU Commission, 2006). A recent study found PFOA in the flue gases from the incinerator of Harlingen, the Netherlands. However Taylor et al. 2014 concluded that waste incineration of fluorotelomer-based polymers does not lead to the formation of detectable levels of PFOA under conditions representative of typical municipal waste incineration in the US.

50.PFOA or its salts may be removed from off-gases by scrubbing such gases with aqueous NaOH (Sulzbach et al., 1999) and K₂CO₃ solutions (Sulzbach et al., 2001) and other treatment methods.

51.Although controlled incineration and off-gas cleaning may be utilized in developed countries, it may not be the most cost-effective and accessible option in all countries.

52.For PFOA formed as a by-product in incineration processes, there is a relation to polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) and other unintentional persistent organic pollutants (POPs) releases formed by combustion. Best available techniques and best environmental practices (BAT/BEP) relevant to unintentionally produced POPs for various types of incinerators and other thermal sources are described in the Stockholm Convention BAT/BEP guidelines relevant to Article 5 and Annex C, in Sections V.A, VI.A and VI.C, including providing for appropriate incineration conditions, reduction of open burning, and flue gas treatment. BAT/BEP as described in these relevant documents are being applied for other unintentionally produced substances such as hexachlorobenzene (HCB), pentachlorobenzene (PeCB), polychlorinated biphenyls (PCB) and PCDD/PCDF and will be effective to a certain extent for PFOA as well. In other words, the technical measures required to minimise releases of unintentionally produced PFOA from incineration are already required to a certain extent according to existing BAT/BEP for incineration processes. Additional costs for implementation of measures to reduce releases of PFOA, enforcement and supervision are therefore considered low, as the control measures for other unintentional POPs are already applied.

53.Monitoring of PFOA, namely for chemical analysis, will induce additional costs, even if monitoring programmes for other POPs (e.g. PCDD/PCDF, HCB and PCB) are already established.  Monitoring capacity for PFOA is needed in developing countries and countries with economies in transition.

Other control measures

54.The USEPA uses a combination of regulatory and voluntary approaches, including Significant New Use Rules and the voluntary PFOA Stewardship Program (OECD, 2015). The USEPA has established health advisory levels for PFOA and PFOS in drinking water at 70 ppt (FR 2016 05-25). In the US State of Vermont, the health advisory level for PFOA in drinking water is 20 ppt.¹² In the US State of New Jersey, the guidance level for PFOA in drinking water is 40 ppt.¹³ In China several actions were taken to restrict PFOA production or PFOA-containing products and to encourage the development of alternatives to PFOA (see para 32 (g)).

55.Australia’s approach to risk reduction is a combination of voluntary and regulators actions. The regulatory approach, implemented under the Industrial Chemicals (Notification and Assessment) Act of 1989 requires industry to provide toxicity data for new substances including PFASs or products containing new PFASs being introduced into Australia. Besides, Australia has been monitoring manufacture, import and use of PFASs (including PFOA-related substances) based on information requested of industry, raising awareness of the chemical industry and the general public through the publication of alerts on long-chain PFASs since 2002. Further, additional data requirements are needed for new per- and poly-fluorinated chemicals for assessment prior to introduction into Australia. Assessment recommendations are set out for new PFASs and existing PFASs reassessed. The import of new PFCs that have improved risk profiles but are still persistent, are being managed (Australia, 2016). Australia has also identified 18 high-priority defence sites where groundwater is contaminated with PFAS including PFOA (IPEN Comments on 1^st draft RME). For PFOS, PFOA and PFHxS, Australia has implemented health based guidance values, expressed as a tolerable daily intake (TDI), for use when investigating contaminated sites and conducting human health risk assessments (Australia Gov. 2017). In Australia, the TDI for PFOA is 0.16 µg/kg of body weight. The drinking water quality value is 0.56 µg/L for PFOA (AU Health Dep., 2017). A recent report describes remediation options for PFOA and PFOA (CRCCARE, 2017).

56.The German commission on human biomonitoring has derived new HBM-I values¹⁴ for PFOS and PFOA. Based on an assessment of the literature on animal and human epidemiological studies which it discussed during its last meeting in May 2016, and following clarification of a few open details, the HBM Commission has decided to set HBM I values for PFOA and PFOS in blood plasma of 2 ng PFOA/mL and 5 ng PFOS/mL (UBA, 2016).

57.In 2006, Canada launched the “Action Plan for the Assessment and Management of Perfluorinated Carboxylic Acids and their Precursors”. As a result, Canada implemented a combination of regulatory and voluntary actions to reduce the risk of PFOA and certain long-chain PFAS. The first measure implemented as an early risk management action prior to the final risk assessment, was a voluntary Environmental Performance Agreement with manufacturers of PFOA and LC-PFCAs. Signatories to the Agreement agreed to reduce the amount of PFOA and long-chain
(C₉-C₂₀) PFCAs in perfluorinated chemicals in commerce by 95% by 31 December 2010, and to eliminate them by 31 December 2015. The 2010 reduction target was met by all signatories and the final report shows that the 2015 target has been met. In 2016, PFOA was prohibited under the Prohibition of Certain Toxic Substances Regulations, with a limited number of exemptions (Canada, 2016c).

58.In 2014, the Danish EPA published a study on groundwater contamination associated with point sources of perfluoroalkyl substances, including PFOA and PFOA-related compounds. Based on the findings of groundwater contamination, a study assessing and proposing health based quality criteria was commissioned. This study led to establishing a sum criterion drinking water limit value for 12 PFASs. The limit value is 0.1 µg/L drinking water and is a sum criterion for the presence of all of the 12 PFASs. The same sum criterion limit value is valid for groundwater and a sum criterion limit value for the same PFASs in soil has been established at 0.4 µg/L (dry soil) (Denmark, 2016). The Danish government has also issued an advisory limit for PFCs in food packaging materials of 0.35 micrograms/cm² of packaging material, in practice acting as a ban.¹⁵

59.Since 2014, the Swedish National Food Agency has health-based guidance values for the sum of commonly occurring PFASs (including PFOA) in drinking water (NFA 2017). Since 2016 a total of 11 PFAS are included in the guidance value. If the sum of PFASs exceeds 90 ng/L actions are recommended to lower the levels as much as possible below this action level. If the sum of PFASs exceed 900 ng/L use of the water for consumption or cooking is not recommended. The Australian Department of Health determined drinking quality values for PFOA and PFOS/PFHxS based on the final health based guidance values. These values will be used in undertaking contaminated site investigations and human health risk assessments across Australia (see AU Health Dep 2017). The USEPA established health advisory levels for PFOA and PFOS in drinking water (see USEPA, 2016). The European Food Safety Authority is currently updating PFOA-related health based guidance values (EFSA, 2017).

60.Norway is conducting ongoing remediation of PFAS contaminated soil due to use of aqueous film forming foams (AFFFs) at airports and fire training areas (Norway, 2016).

61.The Swedish Chemicals Agency has published a strategy for reducing the use of PFASs (Swedish Chemicals Agency, 2016b). PFASs applications which could result in environmental contamination should be minimized and ultimately discontinued. Actions to achieve this aim include prioritizing the implementation of measures for uses that can result in substantial direct releases to the environment and work on the global arena including the Stockholm Convention. PFASs-containing firefighting foams are proposed to be collected and destroyed after being used (with some exemptions) (Sweden Comments on 3^rd draft RME).

62.The use of AFFFs may result in leakage into the ground and contaminate soil and groundwater. The Swedish Chemicals Agency, the Swedish Civil Contingencies Agency and the Swedish Environmental Protection Agency have therefore produced a leaflet to the Swedish Rescue Services with recommendations to reduce the use of AFFFs (Swedish Chemicals Agency, 2017). The Swedish Chemicals Agency has also together with the Swedish Civil Contingencies Agency invested in training and information provision for rescue services. Seminars have been held intended to offer the rescue services tools for extinguishing fires in a manner that minimises any impact on the environment (Sweden Comments on 3^rd draft RME). The commercial airports in Sweden have replaced PFAS with non-fluorinated alternatives that are degraded to carbon dioxide and water when used (IPEN Comments on 2^nd draft RME). The Fire Fighting Foam Coalition has published “Best Practice Guidance for Use of Class B Firefighting Foams” that includes guidance on proper foam selection, containing and eliminating foam discharge, and disposal of foam and firewater (FFFC).¹⁶ Among others, it recommends the use of training foams that do not contain fluorosurfactants for training purposes.

63.Greenpeace’s Detox campaign and the Zero Discharge of Hazardous Chemicals (ZDHC) Programme focus on reducing emissions through wastewater. Voluntary maximum residue limits in water have been already recommended and applied by many companies (e.g. H&M, Adidas, Esprit, etc.) (TM, 2016).

64.The POPRC developed a series of recommendations to deal with the PFOS waste stream that are highly applicable to PFOA, its salts and related compounds as they are used for similar applications. Decision POPRC-6/2 outlines a series of risk reduction measures in short-, medium- and long-term frameworks (for more information, see decision POPRC-6/2 and UNEP, 2017).

65.In 2015, the Swedish Environmental Protection Agency conducted a screening of PFASs (including PFOA) in approximately 500 water samples, including groundwater, surface water, landfill leachate and effluents from sewage treatment plants (Swedish Environmental Protection Agency, 2016). The most significant point sources identified were areas where firefighting foams have been used (airports and firefighting training sites) as well as waste and wastewater treatment facilities. Suggested risk reduction measures include: restriction of the release of PFASs from point sources, limit of the use of PFASs-containing firefighting foams, working internationally to limit the use and emissions of PFASs at industrial sites, and development of remediation techniques for PFASs. In Sweden, a network of all relevant authorities has been established since 2014 to provide support and information to other authorities, counties, municipalities, water producers and others regarding issues around PFASs (including PFOA) such as risk assessment and management (Sweden Comments on 2^nd draft RME).

66.It is assumed that the degradation of fluorotelomer-based polymeric products represents a potential indirect source of PFCAs from degradation during use (e.g. sewage treatment plant sludge from laundering textiles) or disposal (e.g. landfill or incineration) (see Prevedouros et al., 2006, Wang et al., 2014a, Wang et al., 2014b).

67.A number of fluoropolymer and fluoroelastomer producers in many parts of the world have developed and implemented various technologies to recover and recycle PFOA and other fluorinated emulsifiers from their production process, including treatment of off-gases, wastewater streams and fluoropolymer dispersions, so as to reduce emissions and exposure to them. These technologies (BAT/BEP) are summarized in section IV of FOEN, 2017. Some of these technologies may also be used to treat waste streams and products of other relevant industries to reduce emissions and exposure of PFOA and related compounds (FOEN, 2017).

68.In 2014, FluoroCouncil published “Guidance for Best Environmental Practices (BEP) for the Global Apparel Industry, including focus on fluorinated repellent products” (FluoroCouncil, 2014). The guidance recommends a set of basic actions in the following schematic areas for BEP of fluorinated durable water repellents: (1) raise environmental awareness with all employees; (2) follow advice of the Safety Data Sheet (SDS) and Technical Data Sheet (TDS) for the product; (3) use the product only if necessary to obtain effects desired; (4) use only what you need: work with the chemical supplier to set the amount; (5) mix only what will be used in the scheduled run; (6) schedule runs to avoid bath changes and wasted liquors; (7) reuse/recycle residual liquors/surplus of liquors if this can be done without jeopardizing quality; (8) maintain all equipment in excellent working condition and conduct periodic operations audits; (9) optimize drying and curing conditions in the stenter frame; (10) dispose of chemicals appropriately; (11) consider additional opportunities to minimize waste and emissions (see FluoroCouncil, 2014).

69.It is indicated by industry stakeholders that most photo-imaging products do not contain PFOA-related compounds. Waste materials, which are associated with the manufacture of a small number of films containing PFOA-related compounds, are typically disposed by high temperature incineration and excess coating formulations may be sent for silver recovery. Thereby, the waste is incinerated at high temperatures (I&P Europe, 2016a). This represents the situation in Europe (IPEN Comments on 1^st draft RME).

70.Following the listing of PFOA, its salts and PFOA-related compounds in the Stockholm Convention a concentration level for low POP content would be established in cooperation with the Basel Convention, which also typically will be tasked with determining the methods that constitute environmentally sound disposal. Introducing waste management measures, including measures for products and articles upon becoming waste, in accordance with Article 6 of the Convention, would ensure that wastes containing PFOA, its salts and PFOA-related compounds at concentrations above the low POP content are disposed of in an effective and efficient way such that their POPs content is destroyed or otherwise disposed of in an environmentally sound manner. These measures would also address proper waste handling, collection, transportation and storage and ensure that emissions and related exposures to PFOA, its salts and PFOA-related compounds from waste are minimized. Establishment of the low POP value and the guidelines developed in cooperation with the Basel Convention will help Parties to dispose of waste containing PFOA, its salts and PFOA-related compounds in an environmentally sound manner (see Canada, 2016a).

Evaluation of uses and production of short-chain fluorinated alternatives

71.The evaluation aims to identify uses that are needed by society and for which, there may not be accessible chemical and/or non-chemical alternatives. Exemptions in existing regulatory risk management approaches (see Table ) give an indication for the identification of such uses based on technical and socio-economic considerations.

A. Uses in semiconductor industry

72.Industry stakeholders have identified use in semiconductor industry as potentially critical. The Semiconductor Industry Association (SIA) surveyed its member companies and found that several companies continue to use PFOA and related chemicals in the photo-lithography process, a key step in the manufacturing process to produce advanced semiconductors (SIA Comments on 1^st draft RME). This sector is responsible for a very low share of total emissions of PFOA and PFOA-related compounds. The volume used in the sector is a minor part of the total volumes used in the EU and the substances are reported to be used under strictly controlled conditions. Typical control measures are documented in the OECD Emissions Scenario Document No. 9, Photoresist Uses in Semiconductor Manufacturing (OECD, 2010; SIA, 2016).

73.Information submitted by the sector tends to demonstrate that substitution is currently not possible, and that the timeframes for substitution are long (10 years).

74.The public consultations within the EU confirmed that the costs incurred would be high if this use was not derogated. Because of the low amounts used and the fact that emissions are expected to be low, a time limited derogation (until 4 July 2022) for the equipment used to manufacture semiconductors is given in the EU restriction.

75.Besides, derogation without time limitation is given for photo-lithography processes for semiconductors or etching processes for compound semiconductors and for semiconductors or compound semiconductor under the EU restriction (see ECHA 2015c and European Commission, 2017).

76.In Canada, semiconductors in manufactured items are exempted, whereas in Norway an exemption for adhesives, foil or tape in semiconductors terminated in 2016.

77.SEMI (a global industry association serving the manufacturing supply chain for the micro- and nano-electronics industries) supports the exemption for photo-lithography processes for semiconductor manufacturing and highlights that this exemption should take the form of an “acceptable purpose” (SEMI Comments on 2^nd draft RME).

78.Besides, SEMI proposes a number of additional proposals for exemptions and acceptable purposes. In addition to the manufacturing equipment, an exemption without time limit is proposed for their replacement and spare parts. Further, SEMI proposes a five-year exemption for facility-related chemical, gas, and air distribution and control systems for semiconductor manufacturing fabrication facilities as well as a five-year exemption for chemical container systems for the storage, conveyance, and transport of substances or mixtures (SEMI Comments on 2^nd draft RME). In addition, SIA requests that suppliers are provided with an acceptable purpose exemption under Annex B for its uses of PFOA and related compounds in manufacturing “tools” and ancillary equipment. The incorporation of small amounts of PFOA and related compounds into the fluoropolymers used in tools and ancillary equipment, including seals, coatings, valves, gaskets, and containers found in these tools, as well as spare parts is needed to achieve critical performance and functional requirements. These complex pieces of equipment are used in fabrication facilities with minimal potential for exposure. In conclusion, SIA calls for an exemption under Annex B of the Convention for the industry’s uses of PFOA and related compounds in its manufacturing processes and the use of these chemicals in advanced manufacturing equipment (SIA Comments on 1^st draft RME).

B. Technical textiles¹⁷

79.For non-technical textiles used in outdoor applications (e.g. awnings and outdoor furnishing, camping gear), alternatives are available and an exemption is not justified in the EU.

80.For filter materials for oil and fuel filtration some companies claim that no alternatives are available. However, other companies report the availability of alternatives (short-chain fluorinated chemicals) in high performance areas (ECHA, 2014a, 2015a). Overall, it cannot be fully assessed whether an exemption is justified in the professional sector due to data gaps mainly on volumes, specific uses and substances. It could be agreed to grant a transitional period for the remaining uses in the professional sector as personal protection equipment needs to fulfil specific requirements, which are established in respective standards (e.g. standard EN 13034 for protective clothing).

81.For textiles for the protection of workers from risks to their health and safety a time-limited derogation (until 4 July 2023) is given in the EU. The ECHA SEAC proposes a similar exemption for membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment (European Commission, 2017).

82.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, i.e. import, use, sale and offer for sale of textiles containing PFOA, its salts and its precursors are not restricted in Canada.

83.According to the information submitted by the Bavarian Textile and Apparel Association and South-Western Textile Association (VTB SWT), PFOA may occur as an impurity of the production of side-chain fluorinated polymers, which are used as formulations/mixtures for the oil-, water- and chemical-repellent finishing of textiles. Application technique is performed at highest standard and, if at all, only traces of PFOA are transferred by impregnation. As a cross-sectional industry, the professional, technical and protective textile sector of the textile industry has to fulfil many different performance standards in particular medical, chemical, environmental protection as well as

fuel-repellency safety standards for the automotive and aircraft industries. Almost all of these textiles have to be certified in long procedures, which could take years and several textiles are regulated by various other EU- and national laws. These are complemented by standards and regulations of separate enterprises, called in Germany “TL” which could be translated i.e. Technical Performance profile. The German textile industry staff is adequately trained, the occupational health and safety is strictly fulfilled and monitored (VTB SWT, 2016). Technical standards such as those used in Germany could be elaborated as examples of good practice (Netherlands Comments on 2^nd draft RME). However, the PFOA amounts and manufacturing process and conditions in other countries and regions are not known and could be substantial; resulting in human exposure and environmental releases (IPEN Comments on 1^st draft RME).

84.Side chain fluorinated polymers based on PFOA related substances (e.g. 8:2 Fluorotelomer acrylates) used for textile treatment contain 2% unbound residues of PFOA related substances (Russel et al., 2008). These unbound residues can be released to the environment via air and water during the use and waste phase of the treated textile. PFOA related substances can moreover be used in impregnation agents (ECHA 2015a). The European Apparel and Textile Confederation (EURATEX) consider the inclusion of exemption for water, oil- and chemical-repellence crucial for occupational safety. The transitional period of 6 years would enable ongoing and new projects to deliver results for better performing and environmentally friendlier fluorinated and non-fluorinated polymer alternatives within the European REACH process (Euratex, 2016).

85.According to Textile+Mode association, a lot can be done to meet the risk reduction goals. A common practice is the containment technology. It allows the recycling of PFOA and reuse during polymerization and the retention from contaminated air and process wastewater. During the textile refinement, the minimization of emissions is a common practice. The use of best environmental practice (BEP) in production is a major key to avoid emissions and/or to bring them down to a very low level. In the EU technical textiles are produced respecting the BEP. The treatment with fluorinated products has the aim to minimize the influence of the environment by durable oil- and water repellency. The properties have been developed and optimized within the last decades to reach and keep up this high level of protection. Therefore, an exemption for professional, technical and protective textiles, which must meet durable repellency performance standards, is considered indispensable (TM, 2016).

C. Certain printing inks

86.Comments from the industry submitted during the EU public consultation indicate that PFOA and related compounds are present in latex inks used in professional printers. This use only continues in printers that are no longer manufactured, and therefore a phase-out is already underway. There seems to be a clear decreasing trend in the amounts used and related emissions. The company that has manufactured the printers and inks in question claims that in absence of a transitional period of 5 years, there would be a need for premature replacement of the printers in use, and the costs would be high because there would be a loss in image quality. The scientific committee of the EU concluded that it is justified to accept a transitional period of 5 years for latex printing (ECHA, 2015c) so that a time limited derogation (until 4 July 2022) is given in the EU (European Commission, 2017). For water-based inks a time limited exemption (until 31 December 2016) was in place in Canada (Canada Comments on 1^st draft RME). The Norwegian risk management approach, however, only applies to consumer products and does not restrict PFOA use in inks for professional use/printers.

D. Production of short-chain fluorinated alternatives

87.According to FluoroCouncil, industry may perform reprocessing of an unavoidable fraction of PFOA and PFOA related substances as isolated intermediates to produce C₆ fluorotelomer alternatives in another site than the production site and therefore an exemption for transported isolated intermediates is needed (FluoroCouncil Comments on 2^nd draft RME). An exemption for transported isolated intermediates without time limit is given in the EU restriction according to its paragraph 4(c) provided that the conditions in points (a) to (f) of Article 18(4) of the EU Regulation (EC) No 1907/2006 are met (European Commission, 2017). An exemption should also 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 risk management approach, i.e. that the synthesis of (an)other substance(s) from an intermediate takes place on other sites under the following strictly controlled conditions: (1) the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage; (2) procedural and control technologies shall be used that minimise emission and any resulting exposure; (3) only properly trained and authorised personnel handle the substance; (4) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered; (5) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures; (6) substance-handling procedures are well documented and strictly supervised by the site operator.

E. Photo-imaging

88.According to the Imaging and Printing Association Europe (I&P Europe), the primary control measure adopted voluntarily has been to pursue the development of alternatives. Since 2000, the industry has reformulated/ discontinued a large number of products, resulting in a world-wide reduction in the use of PFOA-related compounds of more than 95%. Although replacements do not currently exist for the remaining few applications, further reduction in use of these substances is anticipated as the transition continues towards digital imaging. I&P Europe believes that additional control measures for ongoing uses are not necessary (I&P Europe, 2016a).

89.According to I&P Europe, the non-availability of PFOA-related compounds for the manufacture of the remaining relevant imaging products will also adversely affect involved customer groups such as healthcare and military. In view of the healthcare sector for example, it could be financially challenging for hospitals and doctor's offices with tight budget restraints to invest in new technologies necessitated by discontinuation of current conventional photographic products. It can be expected that such impact is larger in developing countries and in certain EU countries in the medical area such as Italy, Spain, Portugal, Greece and a number of Eastern European countries (I&P Europe, 2016a).

90.Within the EU risk management approach, an exemption is given for photographic coatings applied to films, papers or printing plates (European Commission, 2017). 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 the Canadian approach does not apply to manufactured items. Hence, the import, use, sale and offer for sale of photo media coatings applied to film, papers or printing plates are not restricted in Canada.

F. Nano-coating

91.During the EU public consultation on the restriction dossier, only one company applying coating for smartphone manufacturers requested a derogation for 3 years for pulsed plasma

nano-coating in order to be able to move to an alternative C₆ chemical. (ECHA, 2015c). For plasma nano-coating a time-limited exemption (until 4 July 2023) is given in the EU (European Commission, 2017). The Canadian approach does not apply to manufactured items. Hence, the import, use, sale and offer for sale of coatings applied to smartphones (or other electronic equipment) are not restricted in Canada.

G. Spare parts

92.EU industry stakeholders requested an exemption for spare parts of various types (aviation, telecommunication, semiconductors, information and communications technology industry). The concern relates to the possibility to place on the market and use in the EU spare parts already manufactured at the date of entry into force. According to their comments, in the absence of derogation, those spare parts would have to be destroyed, which would represent an economic loss for EU manufacturers. The ECHA RAC and SEAC found that the derogation for spare parts in stock before the entry into force of the restriction was justified for all applications, including the cases mentioned above as well as other cases), given the costs of their elimination and low emissions associated with their prolonged life (ECHA, 2015c). In the EU restriction, there is no exemption for spare parts (European Commission, 2017).

93.Further, the Canadian Vehicle Manufacturers’ Association (CVMA) requests specific exemptions for automotive service and replacement parts. According to CVMA, the industry has been proactively phasing out PFOA use for some time. However, service and replacement parts might still contain PFOA. These parts represent a small percentage of PFOA use and will decrease naturally over time as the vehicle fleet turns-over. Automotive manufacturers need to ensure the availability of original equipment and spare parts in order to satisfy customer demand (CVMA 2017).According to the information submitted by IPEN, an exemption would also result in ongoing PFOA releases to humans and the environment from production and use.

94.According to SEMI, regarding manufacturing equipment and related infrastructure in the semiconductor industry, a transitional period would be required also for maintenance, spare, replacement, or refurbished parts for legacy equipment or legacy fabrication plant infrastructure (comment SEMI, 2017 on first draft RME).

H. Firefighting foams

95.AFFF is a generic term for firefighting and/or vapor suppression products used globally to extinguish fires. AFFFs were designed to be especially effective in extinguishing Class B (flammable liquids) fires. AFFFs may contain PFOA or PFOA-related substances. Not every situation will necessarily require the use of firefighting foams. Only a careful consideration of the specific situation at hand (emergency incident or design of fire/property protection system) and review of local building codes and other regulations can determine the proper product selection. Over the past decade, AFFF manufacturers have been replacing PFOS-based products with fluorotelomer-based fluorosurfactants. Today most firefighting foams are manufactured with fluorochemicals/telomers based on a perfluorohexane (C₆) chain (further details see UNEP/POPS/POPRC.12/INF/15/Rev.1), but there are fluorine-free foam or other methods of extinguishment alternatives available fulfilling the requirements of efficiency for many areas of use in Class B fires (Swedish Chemicals Agency, 2016a). For firefighting foams containing PFOA-related substances a number of alternatives exist (see paras 158 to 165).

96.To be consistent with the exemption for foams already in use, and to avoid the need for early replacement of exempted foams, SEAC proposed to derogate these mixtures from the EU restriction for 20 years. This is the normal lifetime for firefighting foams, and this time period is supported by comments from the public consultations (ECHA, 2015c). In the European process, despite concerns raised by some firefighters and foam manufacturers that, in high risk chemical plants and large storage areas, fluorine containing foams with a PFOA and related substances content of up to 1,000 ppb would be needed for another 10 years, the European Commission received ample information from two different sources, demonstrating the availability and effectiveness of entirely fluorine free foams. In addition, short chain fluorine based foams already exist. Here, impurities of PFOA and PFOA related substances seem to be a problem, rather than their presence being essential to technical performance. The Commission considered that the general deferral of three years should be a reasonable timeframe for the firefighting foam manufacturing industry to adapt their formulations to the restriction.

97.According to the information submitted by IPEN, the normal lifetime of firefighting foam varies considerably with temperature and storage conditions. 20 years is an inappropriate length of time for continued dispersive use of POPs, a use which has led to massive contamination of groundwater in many countries. Germany, supported by Austria, proposes to include a short transitional period for the use of foams already placed on the market, since the firefighting foams are very stable and may be stored for very long time until used in the case of fire. To avoid continued emissions to the environment from this source, existing foams should be replaced with sustainable/suitable alternatives (Germany Comments on 1^st draft RME; Austria Comments on 2^nd draft RME).

98.Regarding the placing on the market of new AFFFs for professional use, SEAC notes that during the EU public consultations, some stakeholders (firefighting services, foam manufacturers) have requested higher concentration limits for PFOA-related substances and PFOA, or total exemption of firefighting foams. Overall, given the information provided, SEAC proposed to adopt a higher limit value of 1 000 ppb per substance, for both PFOA or for each PFOA-related substance when used in firefighting foam concentrates, and to reconsider this concentration limit with an aim to lower it in the proposed review of the restriction 5 years after entry into force (ECHA, 2015c).

99.Within the EU restriction according to its paragraph 4 (e), an exemption is given for concentrated firefighting foam mixtures that were placed on the market before 4 July 2020 and are to be used, or are used in the production of other firefighting foam mixtures. An exemption is given for firefighting foam mixtures (1) placed on the market before 4 July 2020 or (2) produced in accordance with paragraph 4(e), provided that, where they are used for training purposes, emissions to the environment are minimized and effluents collected are safely disposed of (European Commission, 2017). In Canada, a not-time-limited exemption is given to AFFFs used in firefighting applications (Canada 2016c). There are no exemptions in place for firefighting foams in Norway, however, the risk management approach does not apply since it concerns consumer products and AFFFs are for professional use only. The Canadian Fuels Association (CFA) supports the exemption of AFFFs as proposed in the RME (CFA Comments on 2^nd draft RME).

I. Medical devices

100.In the EU public consultation, stakeholders have indicated that substitution is ongoing but is a lengthy process given the complexity of the supply chains and the certification processes. General transitional period of a minimum of 5 years was requested, but for some devices this transitional period could be too short. In the specific case of implantable medical devices, a manufacturer requested a transitional period of 15 years (ECHA, 2015c).

101.Within the EU restriction, time-limited exemption (until 4 July 2032) is given for medical devices other than implantable medical devices within the scope of Directive 93/42/EEC. In addition, an exemption without time limitation is given for the production of certain implantable devices (European Commission, 2017). Norway has an exemption in place for medical devices (no time limit).

J. Transported intermediate use in the production of pharmaceutical products

102.According to chemical industry, alternatives have not been developed for all pharmaceutical and some other highly specialized chemicals which use PFOA-related chemicals as their raw material and/or processing media and which have socio-economic benefit in particular performance standards (FluoroCouncil, 2016a). There is no information specifying “other highly specialized chemicals”. In the SAICM context environmentally persistent pharmaceutical pollutants are adopted as a global emerging policy issue, while recognizing that pharmaceuticals have major benefits for human health and animal welfare. Perfluorooctyl bromide (PFOB) is produced from perfluorooctyl iodide (PFOI). PFOI is produced at one single site in Japan during the production of 6:2 fluorotelomer-based substances (telomerisation, separation and distillation in closed system), and then transported as isolated intermediate to another site in Japan to produce PFOB. All the wastes generated from this production of PFOI are collected in closed system and are incinerated. A minor amount of emission to the air can be expected and is estimated to be less than 1 kg per year. Afterwards, PFOB is transported to two sites in the US and Sweden to produce relevant pharmaceutical products (Daikin Comments on 2^nd RME and information from IFPMA at POPRC-13).

103.PFOB is used as a processing aid in the manufacture of “microporous” particles for pharmaceutical applications. PFOB is not a PFOA related compound. PFOB does, however, contain unintended trace levels of PFOI, a PFOA related compound. The residual PFOB in the finished “microporous” pharmaceutical products is typically 0.1%, which translates to residual PFOI at levels of 0.1 ppm. The detection limit for PFOB in the porous particles is 0.1%. The PFOI residual in all currently produced pharmaceutical products totals to less than 2g per year. Emission of PFOI to the environment from pharmaceutical production is currently less than 30g total per year. PFOB in process waste is captured in serial carbon beds, which is the best available technology and it controls emissions to less than 1% and typically to less than 0.1% (Information from IFPMA at POPRC-13).

104.The “microporous” particles enable the combination of more than two active pharmaceutical ingredients into one pharmaceutical with desirable ratios to maximize the effect. The microporous particle technology also enables delivery efficiency and targeted delivery in the lungs. The manufactured pharmaceutical products currently marketed are for the treatment of patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF). Research on additional pharmaceutical applications is ongoing in early and late stage development (Information from IFPMA at POPRC-13).

105.Extensive efforts have been made to identify alternative agents, with at least 15 agents screened, but PFOB was found to be the only one suitable for manufacture of the “microporous” pharmaceutical products and to have a suitable toxicological profile that is safe for administration in humans (NDA 020-091 FDA approval of Imagent®). Given these efforts, it is improbable that an alternative agent can be identified without compromising the properties of the “microporous” particles. If an alternative agent was found, this would still require repeat clinical trials and re-registration of the products which total period will be in excess of 10 years. For this type of pharmaceutical products, there is need to secure continuous delivery to patients, hence further consideration on the appropriate way to address this application is required (Information from IFPMA at POPRC-13).

K. Use of sulfluramid

106.N-Ethyl perfluorooctane sulfonamide (known as sulfluramid; EtFOSA; CAS No: 4151-50-2) has been used as an active ingredient in ant baits to control leaf-cutting ants from Atta spp. and Acromyrmex spp. in many countries in South America as well as for control of red imported fire ants, and termites (UNEP/POPS/POPRC.6/13/Add.3/Rev.1). Fluorosurfactants may also be used as “inert” surfactants (enhancers used in pesticide formulations but not constituting active ingredients) in pesticide products (UNEP/POPS/POPRC.12/INF/15/Rev.1).

107.Sulfluramid is used in baits for the control of leaf-cutting ants, according to the delegation from Brazil the use of sulfluramid in Brazil prevents damage corresponding to losses of up to 14.5 % of trees per hectare. Other agricultural products likely to suffer costly losses are soybean and maize. Also, the per-hectare capacity to support livestock is likely to decrease if forage for grazing is reduced by ants (UNEP/POPS/POPRC.12/INF/15/Rev.1).¹⁸

108.Insect baits for control of leaf-cutting ants from Atta spp. and Acromyrmex spp. are listed as acceptable purpose for the production and use of PFOS, its salts and PFOSF in Annex B (UNEP/POPS/POPRC.12/INF/15/Rev.1).

Costs and benefits of implementing control measures

109.In a HELCOM report, cost-effective management options to reduce discharges, emissions, and losses of hazardous substances including PFOA have been assessed. Besides measures at industrial sources, measures at urban sources can also reduce emission of PFOS/PFOA, such as advanced treatment of municipal waste water by activated carbon (further details also in other options see HELCOM, 2013).

110.PFOA has already been phased out widely in many uses, indicating that the costs of alternatives have not inhibited the PFOA substitution. Important points to consider when evaluating the costs of alternatives for any product include the following. Alternatives with a higher initial purchase cost may actually be cheaper over the whole life span of the product when durability and other factors are taken into account. Mass-production of alternatives can significantly lower their costs. The costs of initiatives to protect health and the environment are frequently overestimated in advance and later decline rapidly after the regulation is implemented. Finally, costs of environmentally sound disposal of end-of-life products are also an important factor to take into account (Ackermann and Massey, 2006).

111.For the EU restriction, the substitution costs according to the EU proposal for a restriction have been estimated related to: (1) fluoropolymers import and use of PTFE mixtures; (2) textiles use in the EU; (3) textiles import in article; (4) firefighting foams; (5) paper; and (6) paints and inks. The estimation was made by the industry for the current uses (worst case scenario) and for the time period after the restriction will enter into force (more realistic case). Due to the lack of data, estimation associated with the import of PFOA in articles, photographic applications and semiconductors was not made. The estimated substitution costs for the EU range from 1.39 to 158.44 million euros with a 34.7 million euros central estimate for the more realistic case for the EU (see ECHA, 2015a, Table F.26).

112.The EU public consultation with industry has shown that the main fluoropolymer manufacturers have already developed several alternatives to replace PFOA. These alternatives are often exclusively manufactured and used by each company. As a consequence, there are usually no market prices available (yet). However, there are some indications on the increase in operating costs, which can be used to assess the costs of the proposed restriction to fluoropolymer manufacturers. Accordingly, it is assumed that the use of alternatives induces a low to moderate increase in production costs (0-20%). This increase arises from the higher costs and/or the higher amounts of alternatives that will be used. Industry stated that there is no change in the quality of the PTFE manufactured with the alternatives (ECHA, 2015a).

113.Regarding the investment costs, mainly (former) manufacturers of PFOA and PFOA-related substances industry, stated during the preparation of the EU restriction, that industry has already invested considerable resources to develop short-chain PFASs in terms of R&D efforts and capital (over 500 million euros have been reported, which was also confirmed in the EU public consultation). For downstream users, substantial costs can be expected to switch to short-chain alternatives due to reformulation of products, adapting production processes and testing. In this respect, up to 1 million euros per company have been reported, depending on the specific conditions of the case at hand (ECHA, 2015a).

114.According to I&P Europe, the primary barrier to completely eliminate the use of PFOA-related compounds at this time remains to be technical. However, the costs of research and development are also relevant for consideration, since such investment may represent a significant financial burden during the time when imagining industry is focused on the creation of innovative new digital imagining technologies. The economic costs associated with the substitution of PFOA-related compounds in the few remaining relevant photographic uses have in most cases become prohibitive. The small remaining relevant uses are niche products in markets that IP Europe members anticipate to further decline (I&P Europe, 2016b).

115.For the EU, it has been shown that there are considerable costs to society connected with hypercholesterolemia, developmental toxicity and cancer. These costs will manifest through direct costs such as medical treatment and indirect costs such as loss of life quality for affected individuals. It has not been possible to estimate the share of the overall disease burden that can be attributed to PFOA and PFOA-related substances. However, the large risk characterization ratios imply that there will be significant benefits to human health from restricting PFOA and “PFOA-related substances” (ECHA, 2015a). According to the information from Norway, the socio-economic assessment in the EU emphasized mostly on the persistent, bioaccumulative and toxic (PBT) properties of PFOA for the reason of reducing the emissions. Newer studies have also shown correlations between exposure to PFOA and reduced effects of vaccines and PFOA is presumed to be an immune hazard to humans (see e.g. UNEP/POPS/POPRC.12/11/Add.2. or NTP, 2016).

116.The EU restriction is not expected to lead to wider economic impacts within Europe because the market is already developing towards replacing PFOA and PFOA-related substances. This is reflected by the estimated moderate compliance costs. Furthermore, the restriction is not expected to trigger effects with regard to the competitiveness of the EU and global industry because both will have to substitute PFOA and “PFOA-related substances” to comply with the restriction. The restriction is not expected to have major effects on employment in the EU (ECHA, 2015a).

117.The cost of removing and destroying PFOS that is present in existing products, such as firefighting systems, is generally estimated to be well below 1,000 euros per kilogram, although it can be much higher in individual cases. An example is the Barendrecht railway tunnel in the Netherlands, where at least 3,500 euros per kilogram was spent on removing PFOS from the firefighting system. This operation did not achieve complete removal, which would require a second round of flushing or replacement of the main pipe, costing at least another 400,000 euros per kilogram of the remaining PFOS. The railway operator was not required to do this, which could be interpreted as an indication that the cost was considered disproportionate, although this reason was not put forward explicitly (Oosterhuis et al., 2017).

118.A regulatory initiative has been developed as part of Canada’s Chemical Management Plan (CMP) with the objective to protect the environment from risks associated with the manufacture, use, sale, offer for sale or import of (among other substances) PFOA and long-chain PFCAs. In the Canadian risk management process, scientific evidence has demonstrated that PFOA and long-chain PFCAs are persistent, that they accumulate and biomagnify in terrestrial and marine animals, and that they are toxic to the environment under the Canadian Environmental Protection Act, 1999 (CEPA). Although no quantitative analysis of benefits of the initiative has been conducted, the regulatory controls for PFOA and long-chain PFCAs in Canada will protect the environment. An improvement in environmental quality is expected from controlling these substances.

119.Norway states that control measures will have positive impacts on human health, since we are still exposed to PFAS in our everyday environment (Norway, 2016). The number of consumer products containing PFOA has decreased, and the levels in all-weather clothing have decreased after the introduction of a national regulation of PFOA in consumer products in 2013 (Norway Comments on 2^nd draft RME).

120.In Australia, societal impacts of PFOA have recently come to the fore with the identification of a number of sites contaminated by the historic use of AFFFs at airports and firefighting training facilities to fight liquid fuel fires. Firefighting foams containing PFOA, PFOS and PFHxS have been phased out in a range of uses. It is noted that legacy use of AFFFs has contaminated some defense and civil airport sites, with contamination migrating off-site in some instances through surface and groundwater. The migration of PFOA from the point of use has resulted in the contamination of ground and surface water in adjoining areas that, in some instances, were used for human consumption and agricultural purposes. In sites where drinking water has been contaminated, an alternative source of drinking water has been provided. Some agricultural activities have been affected, for example, market gardens and small scale poultry and egg production, where PFOA has contaminated water previously used for these purposes. The stigma of being in a contaminated environment has led to decreasing property and business values and the loss of income for some land and business owners. This in turn has led to a level of stress and anxiety in the affected communities which is further compounded by the uncertainty of the health impacts of the residents. While the impact on Australia is largely from the legacy use of PFOA-containing AFFFs, the implementation of control measures will provide some assurance to Australian communities that the potential for ongoing or future contamination is being minimized (Australia, 2016). In April 2017, two major spills of PFOA (22,000 and 5,000 litres) containing AFFFs occurred at Brisbane airport and resulted in government warnings to avoid consuming fish from the area’s waterways (IPEN Comments on 2^nd draft RME). The Australian federal government is developing a whole-of-government response and also working in collaboration with Australian States and Territories to manage and respond to PFAS contamination (Australia Comments on 2^nd draft RME).

121.Continued use of PFOA in firefighting foams would result in the ongoing contamination of groundwater and soil surrounding military sites and airports across the world, with all its associated remediation, compensation and legal costs in addition to harms to human health and the environment (Wang et al., 2017; LaSalle, 2016; The Senate Foreign Affairs, Defence and Trade, 2016; Air Services Australia, 2016; Filipovic et al., 2015; Houtz et al., 2016). Recent calculations of the total costs for cleaning up groundwater polluted by PFAS around firefighting areas in Norway show that
3.5-5.5 million euros is required per training site. These numbers include investment and operation of groundwater cleaning systems necessary in some Norwegian airports polluted by PFAS from firefighting foams. Chemical analysis show that PFOA migrates into the ground water to a higher extent than PFOS (Norway Comments on 3^rd draft RME).

122.In 2005 PFAS containing firefighting foam has been used at the German Airport Düsseldorf because of a plane crash and firefighting trainings. PFAS (also PFOA), contaminated soil and leached into groundwater. The PFAS containing groundwater polluted two lakes nearby which are now closed for the public, the consumption of fish is prohibited. In 2007 the local environment authority of Düsseldorf found elevated PFAS levels in the north of Düsseldorf. In the next years the airport Düsseldorf was found to be the main PFAS-source. The remediation of the groundwater will take years or even decades. Further, about 3000 tonnes of soil polluted with PFAS were excavated and disposed of.¹⁹ Other airports in Germany have similar PFC contaminated areas resulting from the use of AFFFs for training purposes in the past (i.e. Nürnberg airport). The costs of such remediation actions are discussed in ECHA, 2015a (Germany Comments on 3^rd draft RME).

123.In Germany, there are is one prominent case showing the consequences of (illegal) disposal of waste/sludge on agricultural fields. Because of the disposal of industrial sludge PFOA leached into the surrounding surface water and a drinking water reservoir, Lake Möhne, was polluted (see Skutlarek et al. 2006, Wilhelm et al. 2009, Wilhelm et al. 2010, Hölzer et al. 2008, Hölzer et al. 2009). The drinking water thus contained elevated levels of PFOA. Thus, human biomonitoring studies showed higher PFOA levels in blood from people living in Arnsberg compared to inhabitants of a nearby area which received drinking water from a different source. According to information from the media the purification costs for the groundwater of about 2.5 million euros have been incurring since 2006. The purification plant will be operated during the next years and operating costs are about 100,000 euros per year (Germany Comments on 3^rd draft RME).²⁰

124.High levels of PFAS in drinking water, in the µg/L range, have been detected since 2011 in a number of municipalities in Sweden. The costs for addressing PFAS contamination of drinking water for some municipalities are provided such as charcoal filtering of water in Uppsala (annual cost 1 million euros) and new water supply in Ronne by (3 million euros) (Swedish Environmental Protection Agency, 2016). Firefighting training sites have been shown to be the main sources of this pollution, which in some cases have resulted in water supplies being closed. The municipalities have released information that wild fish caught from lakes downstream pollution area should not be eaten too often (Swedish Chemicals Agency, 2013). For PFAS-containing water derived from a cavern near an old airfield, a carbon filter system has been installed to clean 150-200 m³ of water from the caverns before it flows out into receiving waterways (Defoort et al. 2012). PFAS have also contaminated drinking water for 15 million inhabitants and several sites in USA. However, carbon filter systems may not work for all PFAS (Wang et al., 2017).

125.Regarding professional, technical and protective textiles, the sales of German manufacturers in 2013 amounted up to 6 billion euros (see VTB SWT, 2016 and TM, 2016).

126.Due to accessibility or costs of alternative technologies, some of alternative technologies for PFOA in developing countries may be available a few years later