Risk Management Evaluation Endosulfan

38.Switzerland provides information on the unintentional formation of PFOA from inadequate incineration of fluoropolymers e.g. from municipal solid waste incineration (MSWI) with inappropriate incineration or open burning facilities at moderate temperatures. Some recent studies qualitatively show that small, but measurable amounts of PFOA and a wide range of other PFCA homologues can be generated during the thermolysis of non-functionalized PTFE (Ellis et al., 2001, 2003; Schlummer, 2015) and functionalized PTFE (Feng et al., 2015) at temperatures between 250°C and 600°C. This may be particularly critical for developing countries and countries with economies in transition, where wastes are often not incinerated to sufficiently high temperatures and without proper treatment of flue gases due to a lack of adequate facilities (see FOEN, 2017). 15

39.National and regional control actions differ with regard to their chemical scope and exemptions (see Table ). The chemical scope of the possible measures discussed in the present risk management evaluation has a different scope compared to other regulatory risk management approaches and is based on principles and obligations of the Stockholm Convention. It is noteworthy that PFOA-related compounds for the purposes of this risk management evaluation covers degradation to PFOA from long-chain PFASs with more than eight perfluorinated carbon atoms except for those explicitly excluded in the definition of PFOA-related compounds as they do not degrade to PFOA under natural conditions (see para 21). This goes beyond the EU risk management approach which does not cover the degradation to PFOA from long-chain PFASs. The degradation from long-chain PFASs is also not considered in the Norwegian risk management approach. The Canadian risk management approach also applies to long-chain PFCAs, their salts, and their precursors. However, long-chain PFASs have been included on Norway’s priority list of substances whose release to the environment should be eliminated by 2020, and they are included in the US Stewardship Program (IPEN Comments on 2nd draft risk management evaluation (RME)). A general definition of
“long-chain PFCAs” (CnF2n+1COOH, n≥7) is provided by the OECD (OECD, 2017). As a result of the existing production processes, fluorotelomer-based substances have been generally manufactured as mixtures of homologues with a range of perfluoroalkyl chain lengths (for examples, see DuPont, 1998), including those that have more than eight perfluorinated carbon atoms. Therefore, the information provided in the present risk management evaluation covers to a certain extent also those fluorotelomer-based substances with longer chain PFAS (longer than 8:2). 15

40.Table gives an overview on the regulatory risk management approaches and exemptions in Canada, the EU and Norway. Section 3 in the background document (UNEP/POPS/POPRC.13/INF/6) provides further details on the legislative approaches in these countries. 16

41.Specific information on the long-chain PFASs was not submitted to the Secretariat with the Annex F submissions of Parties and observers. Moreover, the long-chain PFASs are not considered in the socio-economic assessments of the regulatory risk management approaches in the EU and Norway. Accordingly, the information in the present risk management evaluation does not explicitly cover long-chain PFASs so far. At EU level, Germany and Sweden prepared a restriction proposal for the long-chain PFCAs of chain lengths between 9 and 14 carbon atoms and related substances. The conclusion of the risk assessment is that, despite that no intentional uses in the EU were identified so far, a restriction on a Union-wide basis is justified to reduce the release of these substances into the environment and to prevent any future manufacturing, placing on the market and use. This EU-wide measure may be the first step for global action. 18

42.The control measure may be achieved in different ways under the Convention: 18

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. 18

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. 19

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 1st draft risk RME). 19

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). 19

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. 19

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. 19

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. 19

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. 20

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. 20

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. 20

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. 20

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. In the US State of New Jersey, the guidance level for PFOA in drinking water is 40 ppt. 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)). 20

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 1st 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). 21

56.The German commission on human biomonitoring has derived new HBM-I values 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). 21

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). 21

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. 21

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). 22

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). 22

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 3rd draft RME). 22

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 3rd 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 2nd 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). Among others, it recommends the use of training foams that do not contain fluorosurfactants for training purposes. 22

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). 23

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). 23

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 2nd draft RME). 23

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). 23

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). 23

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). 23

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 1st draft RME). 23

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). 24

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. 24