Risk Management Evaluation Endosulfan



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UNITED
NATIONS


unep-un

SC

UNEP/POPS/POPRC.13/7/Add.2

sc bw notext

Stockholm Convention
on Persistent Organic
Pollutants


Distr.: General
16 November 2017

Original: English



Persistent Organic Pollutants Review Committee
Thirteenth meeting

Rome, 1720 October 2017



Report of the Persistent Organic Pollutants Review Committee on the work of its thirteenth meeting

Addendum

Risk management evaluation on pentadecafluorooctanoic acid
(CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and
PFOA-related compounds

At its thirteenth meeting, by its decision POPRC-13/2, the Persistent Organic Pollutants Review Committee adopted a risk management evaluation on pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds on the basis of the draft contained in the note by the Secretariat (UNEP/POPS/POPRC.13/3), as revised during the meeting. The text of the risk management evaluation as adopted is set out in the annex to the present addendum. It has not been formally edited.


Annex

PFOA, ITS SALTS AND PFOA-RELATED COMPOUNDS

RISK MANAGEMENT EVALUATION

October 2017




Contents

Stockholm Convention
on Persistent Organic
Pollutants 1


Executive Summary 4

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 compounds 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). 4


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. 4

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

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). 4

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). 4

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. 5

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. 5


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. 5

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. 6

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. 6

11.PFOA is unintentionally formed from incomplete combustion of fluoropolymers. 6

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: 6

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: 6


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: 7

15.For the applications above, information regarding socio-economic aspects as well as other relevant information is also welcomed. 7

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. 7


Introduction 8

17.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 compounds in Annex A, B, and/or C of the Stockholm Convention (UNEP/POPS/POPRC.11/5). This proposal was considered by the Persistent Organic Pollutants Review Committee (POPRC) at its eleventh meeting held in October 2015, where the Committee concluded that PFOA fulfilled the screening criteria in Annex D and that issues related to the inclusion of PFOA-related compounds that potentially degrade to PFOA and the inclusion of PFOA salts should be addressed in the draft risk profile (see decision POPRC-11/4). 8


18.The substances covered by the risk profile are PFOA including its isomers, its salts and
PFOA-related compounds. At its twelfth meeting held in September 2016, by its decision
POPRC-12/2, the Committee adopted the risk profile (UNEP/POPS/POPRC.12/11/Add.2) and decided to establish an intersessional working group to prepare a risk management evaluation that includes an analysis of possible control measures for PFOA, its salts and PFOA-related compounds in accordance with Annex F to the Convention. Further, the Committee invited Parties and observers to submit to the Secretariat the information specified in Annex F before 9 December 2016. 8


19.Consistent with the risk profile, this risk management evaluation focuses on PFOA including isomers, its salts and PFOA-related compounds. This risk management evaluation is accompanied by a background document (UNEP/POPS/POPRC.13/INF/6), and to assist with the identification of
PFOA-related compounds a non-exhaustive list of substances covered or not covered by the risk management evaluation is also provided (UNEP/POPS/POPRC.13/INF/6/Add.1). 8


20.PFOA, its salts and PFOA-related compounds fall within a family of perfluoroalkyl and polyfluoroalkyl substances (PFASs). Perfluorinated acids, like PFOA, are not degradable in the environment and in biota (including humans). Certain polyfluorinated substances can be degraded to persistent perfluorinated substances like PFOA under environmental conditions and are therefore precursors. Those PFASs that can be degraded to PFOA in the environment and in biota are referred to as PFOA-related compounds. 8

21.The risk management evaluation covers: 8

22.Data on PFOA are summarized in Table 1 and Table 2. Tables with data for PFOA salts and PFOA-related compounds are provided in a background document to the risk profile (see section 1.1 of document UNEP/POPS/POPRC.12/INF/5). 9

23.Major synthesis routes of fluorotelomer-based substances including side-chain fluorinated polymers as well as an overview of the syntheses routes of major fluoropolymers are illustrated in two figures of supplementary information provided by the Swiss Federal Office for the Environment (FOEN) (see section I of FOEN, 2017). Moreover, specific information regarding the transformation/degradation of fluorotelomers to PFOA is summarized in that document (see section II of FOEN, 2017). 10

24.There are two manufacturing processes to produce PFOA, its salts and PFOA-related compounds: electrochemical fluorination (ECF) and telomerization. From 1947 until 2002, the ECF process was mainly used to manufacture ammonium perfluorooctanoate (APFO; ammonium salt of PFOA) worldwide (80-90% in 2000) which results in a mixture of branched and linear isomers
(78% linear and 22% branched isomers). In the ECF process, octanoyl fluoride is commonly used to make perfluorooctanoyl fluoride that was further reacted to make PFOA and its salts (Buck et al., 2011).In addition, some manufacturers have used the telomerization process to produce linear PFOA and related compounds. In the telomerizationprocess, an initial perfluoroalkyl iodide (telogen) reacts with tetrafluoroethylene (taxogen) to yield a mixture of perfluoroalkyl iodides with different perfluoroalkyl chain lengths (Telomer A). Telomer Aare reacted further to insert ethylene and create fluorotelomer iodides (Telomer B), which are then used to make a variety of fluorotelomer-based products. Another study suggests that ECF is still used by some manufacturers in China (Jiang et al., 2015). The global production of PFOA using ECF is still ongoing, whereas most of the manufacturers using telomerization have ceased their production of PFOA and related compounds (Wang et al., 2014a). 10


25.ISO Standard ISO 25101:2009 specifies a method for the determination of the linear isomers of PFOA in unfiltered samples of drinking water, ground water and surface water (fresh water and sea water) using high-performance liquid chromatography-tandem mass spectrometry (HPLC MS/MS). The method is applicable to a concentration range of 10 ng/L to 10 000 ng/L for PFOA. Depending on the matrix, the method may also be applicable to higher concentrations ranging from 100 ng/L to 200 000 ng/L after suitable dilution of the sample or reduction in sample size (ISO 2009). According to a summary of PFOA-methods in ECHA, 2015a, quantification limits vary dependent on the method from 1 ppb to 2000 ppb (further details see ECHA, 2015a,b,c). The unique chemical and physical properties of PFOA prevent it from being measured using conventional analysis. More complex analytical techniques using liquid chromatography and tandem mass spectrometry (LC/MS-MS) have been proven most reliable for analyzing PFOA in biological and environmental samples, and therefore, are the analytical methods of choice (Xu et al., 2013; EFSA, 2008; Loos et al., 2007). This type of analysis has allowed for sensitive determination of many PFASs including PFOA in air, water, and soil (ATSDR, 2015). 11

26.At its eleventh meeting (decision POPRC-11/4), the Committee concluded that the proposal by the EU to list pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds meets the criteria set out in Annex D to the Convention (UNEP/POPS/POPRC.12/11). 11

27.Based on the draft risk profile for pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in accordance with paragraph 6 of Article 8 of the Convention (UNEP/POPS/POPRC.12/11), the Committee adopted the risk profile for pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and
PFOA-related compounds (UNEP/POPS/POPRC.12/11/Add.2) and: 11


28.Decided, in accordance with paragraph 7 (a) of Article 8 of the Convention, that pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and
PFOA-related compounds are likely as a result of their longrange environmental transport to lead to significant adverse human health and/or environmental effects such that global action is warranted; 11


29.Also decided, in accordance with paragraph 7 (a) of Article 8 of the Convention and paragraph 29 of the annex to decision SC-1/7 of the Conference of the Parties, to establish an intersessional working group to prepare a risk management evaluation that includes an analysis of possible control measures for pentadecafluorooctanoic acid (CAS No: 335-67-1, PFOA, perfluorooctanoic acid), its salts and PFOA-related compounds in accordance with Annex F to the Convention; 11

30.Invited in accordance with paragraph 7 (a) of Article 8 of the Convention, Parties and observers to submit to the Secretariat the information specified in Annex F before 9 December 2016. 11

31.This risk management evaluation is primarily based on information that has been provided by Parties to the Convention and observers. Information specified in Annex F forms was submitted by the following Parties: 11

32.In addition to the above-mentioned references and comments received from Parties and observers, information has been used from open information sources as well as scientific literature (see list of references). The following key references were used as a basis to develop the present document: 12

33.A review of PFOS and PFOA was conducted under the Oslo/Paris Commission for the Protection of Marine Environment of the North East Atlantic (OSPAR) in order to assess the potential impact upon the environment. This resulted in the inclusion of PFOS on the list of chemicals for priority action in 2003, while PFOA was not added to the list at that time (OSPAR, 2006). 12

34.Perfluorinated chemicals and the transition to safer alternatives is one of the issues of concern recognised by the Strategic Approach to International Chemicals Management (SAICM). Activities by SAICM focus on gathering and exchanging information on perfluorinated chemicals and to support the transition to safer alternatives. This work has been coordinated by the Global Perfluorinated Chemicals Group, which is supported by the Organization for Economic Co-operation and Development (OECD) and UNEP. 12

35.An overview related to risk reduction approaches for PFASs was provided by OECD (OECD, 2015). The document includes information on existing risk reduction approaches in countries including voluntary risk reduction measures taken by corporations (see pp. 61 to 64 in OECD, 2015). According to the risk profile (UNEP/POPS/POPRC.12/11/Add.2) and Annex F submissions, national and/or regional regulations related to PFOA comprise the following: 12

Summary information relevant to the risk management evaluation 15

36.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. PFOA-related compounds, including side-chain fluorinated polymers, are used as surfactants and surface treatment agents (e.g. in textiles, paper and paints, firefighting foams). PFOA, its salts and PFOA-related compounds are used in a wide variety of applications and consumer products across many sectors (UNEP/POPS/POPRC.12/11/Add.2). 15

37.Releases occur from past and ongoing production and use. Direct releases to the environment occur from the production of the raw substance (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 water, wastewater and dust particles. Historic releases to the environment from PFOA manufacturing are available from a plant in the US into air and water between 1951 and 2003. Some estimates of releases during the disposal of the chemical are available, particularly from sewage treatment plants, wastewater treatment plants and landfill sites. Indirect releases occur from the degradation or transformation of precursors. PFOA-related compounds are released to air, water, soil and solid waste and will degrade to PFOA in the environment and in organisms. An assessment of sources of PFOA to the Baltic Sea estimated that 30% of the releases were due to transformation of fluorotelomers. Thus, releases of PFOA from degradation of PFOA-related compounds contribute a substantial share to the releases of PFOA to the environment (UNEP/POPS/POPRC.12/11/Add.2). Additional information regarding the transformation/degradation of fluorotelomers to PFOA is summarized in section II of FOEN, 2017. A summary of further risk profile information is given in section 3.1. According to a study from 2008, perfluorocarbons (PFCs) are widely used in aluminium production and emissions of PFCs (possibly including PFOA; not specified in the study) occur during specific electrolysis processes in aluminium manufacturing (see EP 2008). 15

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