Risk Management Evaluation Endosulfan

Summary of risk management evaluation information

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.

Summary of efficacy, efficiency and availability of appropriate alternatives

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 ).

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.

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.

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.

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.”³⁵ 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.

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.³⁶ 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.

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.

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.

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.

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.

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.

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.

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).

Summary of information on impacts on society

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.

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.

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.

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.

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.

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.