Risk Management Evaluation Endosulfan

Executive Summary

1.In June 2015 the European Union (EU) and its member States submitted a proposal to list pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and
PFOA-related compounds¹ in Annexes A, B, and/or C to the Stockholm Convention (UNEP/POPS/POPRC.11/5). At its twelfth meeting in September 2016, the Persistent Organic Pollutants Review Committee (POPRC) concluded that PFOA is persistent, bioaccumulative and toxic to animals including humans. There is widespread occurrence of PFOA and a number of PFOA-related compounds in environmental compartments and in biota and humans. Therefore, PFOA, its salts and PFOA-related compounds that degrade to PFOA are likely, as a result of their long-range environmental transport, to lead to significant adverse human health and/or environmental effects such that global action is warranted (UNEP/POPS/POPRC.12/11/Add.2).

2.The scope of the chemicals covered is defined in paragraph 21 of the risk management evaluation (UNEP/POPS/POPRC.13/7/Add.2) and a comprehensive list of substances is available in document UNEP/POPS/POPRC.13/INF/6/Add.1.

3.PFOA, its salts and PFOA-related compounds are used in a wide variety of applications and consumer products across many sectors (details see UNEP/POPS/POPRC.12/11/Add.2). PFOA and its salts are, or were, most widely used as processing aids in the production of fluoroelastomers and fluoropolymers, with polytetrafluoroethylene (PTFE) being an important fluoropolymer used in producing, e.g. non-stick kitchen ware. PFOA-related compounds, including side-chain fluorinated polymers, are used as surfactants and surface treatment agents, e.g. in textiles, paper, paints, firefighting foams. Based on the available information in the risk management evaluation, these were the uses with the highest amount of PFOA.

4.Releases occur from past and ongoing production, use and disposal. Direct releases to the environment of PFOA and/or related compounds occur from the production of the raw substances (including PFOA as impurity in the manufacturing of PFOA-related compounds and some alternatives) during the processing, use and disposal of the chemical, from treated articles and from products contaminated with PFOA. Main emission vectors of PFOA and its salts are wastewater and particles/aerosols. Indirect releases of PFOA occur from the biotic and abiotic (photo-) degradation or transformation of precursors. PFOA-related compounds, as defined in para 21, are released to air, water, soil and solid waste, and will, to a greater or lesser degree, degrade to PFOA in the environment and in organisms. Releases of PFOA from degradation contribute a major share to the releases of PFOA in some local environment, e.g. remote inland environments (details see UNEP/POPS/POPRC.12/11/Add.2).

5.The activities of the Strategic Approach to International Chemicals Management (SAICM) at the global level focus on gathering and exchanging information on perfluorinated chemicals and to support the transition to safer alternatives. Voluntary efforts to phase out PFOA and related substances have been implemented, such as the United States Environment Protection Agency (USEPA) PFOA Stewardship Program and work by industry. In 2006, the eight main manufacturers of fluoropolymers and fluorotelomers in the US, Europe and Japan agreed on a phase-out of their production and use of PFOA and related long-chain substances by the end of 2015. A similar program existed with manufacturers in Canada. All Stewardship Program participants were successful at virtually eliminating those chemicals from facility emissions and product content. The voluntary phase out did not include manufacturers using PFOA in countries who were not part of the voluntary efforts, i.e. including those having large manufacturers and/or users of PFOA like China, India and Russia (details see UNEP/POPS/POPRC.12/11/Add.2).

6.Regulatory risk management approaches are implemented or underway in several national legislative control actions i.e. Norway, EU (existing restriction) and in Canada. These actions prohibit manufacture, making available on the market and use of PFOA, its salts and PFOA-related compounds with exemptions (time-limited or not). Based on technical and socio-economic assessments, these risk management approaches are considered technically and economically feasible. In 2016 Canada published legislation which prohibits PFOA, its salts and precursors as well as products containing them, unless present in manufactured items, and with a limited number of exemptions. Norway bans the use of PFOA in consumer products and textiles since 2014 with certain exemptions. The EU restricts the manufacture, placing on the market and use (including import) of PFOA, its salts and PFOA-related compounds as well as articles containing these substances. The EU risk management approach considers exemptions for certain uses; however, it does not cover the degradation to PFOA from long-chain perfluoroalkyl and polyfluoroalkyl substances (PFASs). In the US a rule proposed in 2015 would require manufacturers of PFOA and PFOA-related chemicals to notify new uses of these chemicals to USEPA in order to allow the evaluation of new uses and, if necessary, take action to prohibit or limit the activity.

7.In the processes of developing the regulatory risk management approaches for PFOA, its salts and
PFOA-related compounds in Canada, the EU and Norway, technical and socio-economic information has been included in the decision-making process to allow for certain exemptions. In general, these risk management approaches are considered technically and economically feasible. Information received from industry stakeholders during these regulatory processes indicates that exemptions with or without time limitation were needed for certain uses where stakeholders asserted and scientific committees concluded that alternatives were not economically and/or technically feasible. A prohibition of PFOA, its salts and PFOA-related compounds with possible specific exemptions for certain uses is also considered to be technically and economically feasible under the Stockholm Convention.

8.The information on the availability of alternatives considering efficacy and efficiency indicates that appropriate alternatives may currently not be available for several uses, namely: (1) equipment used to manufacture semiconductors and related infrastructure; (2) latex printing inks; (3) textiles for the protection of workers from risks to their health and safety; (4) membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment; (5) plasma nano-coatings; (6) medical devices; (7) production of implantable medical devices; (8) photographic coatings applied to films, papers or printing plates; (9) photo-lithography processes for semiconductors or in etching processes for compound semiconductors; (10) certain pharmaceutical chemicals; and (11) use of sulfluramid. However, for most of these uses, the development of alternatives is underway. In restricting or banning PFOA, its salts and PFOA-related compounds under the Stockholm Convention, this could be considered with specific exemptions with time limits or acceptable purposes without time limits.

9.Similarly, as expected for the Canadian, Norwegian and the EU approaches, globally restricting or prohibiting PFOA, its salts and PFOA-related compounds will positively impact human health, the environment including biota, and agriculture by decreasing emissions and subsequently exposure. The full magnitude and extent of the risks of PFOA, its salts and PFOA-related compounds cannot be quantified. The risk management of these substances is driven by scientific data and precautionary actions to avoid the potentially severe and irreversible adverse impacts resulting from continued unrestricted emissions. The available alternatives are expected to pose lower health risks than an unrestricted use of PFOA, its salts and PFOA-related compounds.

10.The EU, Norwegian and the Canadian risk management approaches are considered to have moderate cost impacts because the market is already replacing PFOA, its salts and PFOA-related compounds and because the risk management approaches provide exemptions for certain uses with or without time limits. The same can be expected for the combined regulatory and voluntary approaches taken in the US and Australia. Cost competitive alternatives to PFOA, its salts and PFOA-related compounds that do not exhibit persistent organic pollutants (POPs) characteristics have already been implemented in many countries. This indicates partial economic and technical feasibility of alternatives. Substituting these compounds with appropriate alternatives leads to savings of health and environmental costs resulting from decreased exposure. Furthermore, a restriction or prohibition would prevent further contamination of surface water, groundwater and soil and would thus reduce costs for identification and remediation of contaminated sites.

11.PFOA is unintentionally formed from incomplete combustion of fluoropolymers.

12.The Committee recommends, in accordance with paragraph 9 of Article 8 of the Convention, that the Conference of the Parties to the Stockholm Convention consider listing and specifying the related control measures of PFOA, its salts and PFOA-related compounds:

13.Based on the evaluation of uses and the efficiency and efficacy of possible control measures, the Committee recommends to the Conference of the Parties that it consider listing pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and
PFOA-related compounds in Annex A or B to the Convention with specific exemptions for the following:

(a) For five years from the date of entry into force of the amendment in accordance with Article 4:

(i) Manufacture of semiconductors or related electronic devices:

a. Equipment or fabrication plant related infrastructure containing fluoropolymers and/or fluoroelastomers with PFOA residues;

b. Legacy equipment or legacy fabrication plant related infrastructure: maintenance;

c. Photo-lithography or etch processes;

(ii) Photographic coatings applied to films;

(iii) Textiles for oil and water repellency for the protection from dangerous liquids for the protection of workers from risks to their health and safety;

(b) For ten years from the date of entry into force of the amendment for manufacture of semiconductors or related electronic devices: refurbishment parts containing fluoropolymers and/or fluoroelastomers with PFOA residues for legacy equipment or legacy refurbishment parts;

(c) For use of perfluorooctane iodide, production of perfluorooctane bromide for the purpose of producing pharmaceutical products with a review of continued need for exemptions. The specific exemption should expire in any case at the latest in 2036.

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

(a) Membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment: information on the scope of the applications, used amounts, availability of alternatives and socio-economic aspects;

(b) Transported isolated intermediates in order to enable reprocessing in another site than the production site: information on the quantities used, extent of transport and risks, and use;

(c) Medical devices: information on specific applications/uses and timelines foreseen as needed for potential related exemptions;

(d) Implantable medical devices: information on the quantities used, extent of transport and risks, and use;

(e) Photo imaging sector: information on paper and printing, and information relevant for developing countries;

(f) Automotive industry: information on spare parts;

(g) Firefighting foams: information on chemical composition of mixtures and the volumes of pre-installed amount of firefighting foam mixtures.

15.For the applications above, information regarding socio-economic aspects as well as other relevant information is also welcomed.

16.In addition, the Committee will collect and evaluate in the intersessional period additional information in the view of a possible listing of PFOA in Annex C from Parties and observers information that would assist the further evaluation by the Committee of PFOA, its salts and

PFOA-related compounds in relation to its unintentional formation and release, in particular from primary aluminum production and from incomplete combustion. In doing so, relevant experts serving under the various technical and scientific processes under the Stockholm and Basel Conventions as indicated in decision SC-8/21 are especially invited to provide input.