Document MJRQGMbdyE62jZ2VZb3wxrJ0j

Sec on III Submission Scope of restric on op on analysis As dra ed, the scope of the Annex XV restric on proposal concerning polyfluoroalkyl substances (PFASs) covers a wide range of chemicals including gases, liquids and solids. These PFAS's have significantly different proper es and are u lised in a very wide range of industries and applica ons. This submission is par cularly concerned with the inclusion of fluoropolymers (such as PTFE and PFA) in the restric on proposal, specifically used in the lining of process pipework and associated equipment in the pharmaceu cal, semiconductor, fine chemicals manufacture1, bulk chemicals manufacture, water treatment and the oil and gas industries. PTFE / PFA fluoropolymer lined pipework and valves are used in the produc on of semi-conductors, medicines, drugs, food stuffs, petrochemicals, and fresh water. In general, they convey highly corrosive media such as hydrochloric, sulfuric, nitric acids etc, prevent spillage and leakage of these substances whilst maintaining their purity by preven ng contamina on from the steel pipework structure. At present, PTFE / PFA fluoropolymers are the only pipe / valve lining that can withstand the nature of the corrosive media, maintain the required purity levels, and tolerate wide-temperature varia ons necessary in many of the processes. These fluoropolymers are the only sustainable material of choice for almost every process industry, where they serve as linings for vessels, piping, pumps, valves, columns, column internals, hoses, expansion joints, seals and gaskets. They provide durable low cost, low maintenance, reliable alterna ves to more expensive and unsustainable exo c metal alloys. The current scope of the restric on fails to consider these very significant uses of fluoropolymers, and the significant consequences of the proposed ban. Therefore, it is necessary that such PTFE / PFA fluoropolymers should be removed from the current restric on proposal. Hazard or exposure The produc on of PTFE is now possible without the use of any surfactants such as perfluorooctanoic acid (PFOA), which has been associated with environmental and health concerns. So, when carried out in a suitable environment PTFE and PFA manufacture is a considered to be a safe process. In addi on, use as pipe and associated equipment linings, PTFE / PFA fluoropolymers are electrochemically, biochemically, enzyma cally and chemically virtually inert. Unlike some other PFAS molecules, fluoropolymers are considered to be non-bio-accumula ve, non-bio-available, non- 1 Fine chemicals are typically high purity, complex molecules that are used as ac ve ingredients, intermediates, or raw materials in the manufacture of pharmaceu cals, agrochemicals, flavours, fragrances, and other specialty chemicals. They are o en produced through mul -step chemical synthesis and require specialized exper se and equipment for their produc on. 1 hazardous, insoluble (and therefore not mobile in water), non-toxic (locally or systemically), and are classed as polymers of low concern by the OECD2. CRP has been processing fluoropolymers for over 40 years with annual staff health checks with no related ill health incidents. Many of the staff have worked for the company for more than 20 years. Informa on on alterna ves At present there are no known pipe/valve lining materials in development that will provide equivalent, or similar, proper es, able to withstand such harsh environments and high temperatures to fluoropolymers irrespec ve of cost/price. More expensive op ons include glass lined steel, or exo c metal pipes/coa ngs and in some circumstances, these materials may be suitable alterna ves for handling par cular individual chemicals (see a;ached Flowserve documents, "Selec ng Corrosion Resis ng Alloys" and "Guide to the Selec on of Corrosion Resis ng Non-Metallics"). However, even these alterna ves are more limited in the type of media and temperatures they can withstand. Turning to consider the alterna ve materials in a li;le more detail: Glass lined piping. Over the last 2 - 3 decades industry has largely moved away from this product range, simply because the glass linings are bri;le and can be easily damaged. Damaged linings lead to product failure, varying from minor leaks, product contamina on through to catastrophic failures. Such events result in environmental damage and poten ally loss of human life. Exo c metallic pipework (such as hastelloy, inconel, incoloy, tanium, and tantalum). This pipework is in the order of 2 to 10 mes more expensive than fluoropolymer lined pipework, making it economically unviable compared to PTFE / PFA fluoropolymer lined in almost all circumstances. In addi on, while each individual material may be suitable for a specific duty, o en it is not suitable for the range of du es that individual manufacturers require. Also, due to its lack of universal corrosion resistance there is a danger that an unsuitable chemical will be put through such pipework, leading to failure, with all of the associated costs and hazards to personnel and the environment. Finally, the extrac on and processing of these rare metals brings addi onal environmental considera ons, par cularly when this is done in countries with less stringent environmental protec on legisla on, such as: Khazakstan, India, Albania (chromium); Indonesia, Russia (nickel); Sierra Leone, Russia ( tanium); Democra c Republic of Congo, Rwanda, Brazil (tantalum). Please refer to the following documents which accompany this submission: (i) Summary of Flowserve Corrosion Data. This provides a summary of the data found in the addi onal two documents. It highlights the different performance characteris cs of PTFE / PFA fluoropolymers compared to the various alterna ves available today. This shows how every other alterna ve has inferior performance characteris cs to that of PTFE / PFA fluoropolymers. Add in the implica ons in terms of cost and physical performance then it is clear that there isn't a viable alterna ve for many produc on processes at this me. 2 A Cri cal Review of the Applica on of Polymer of Low Concern and Regulatory Criteria to Fluoropolymers. Barbara J Henry, Joseph P Carlin, Jon A Hammerschmidt, Robert C Buck, L William Buxton, Heidelore Fiedler, Jennifer Seed, and Oscar Hernandez 2 (ii) Flowserve Publica on, "Guide to the Selec on of Corrosion Resis ng Alloys" (iii) Flowserve Publica on, "Guide to the Selec on of Corrosion Resis ng Non-Metallics" Consequently, if PTFE / PFA fluoropolymers were to be banned, leaving only glass or exo c metal lining op ons there are a number of consequences: (i) Many pharmaceu cal plants run a batch manufacturing process, making a batch of one drug, followed by a batch of a different type with a different set of parameters. Piping lined with PTFE / PFA fluoropolymer can easily accommodate this due to its broad suitability to cope with a wide range of circumstance. If fluoropolymers were to be banned, such mul purpose plant would cease to be possible, again making such manufacturing less compe ve in the EU. (ii) To cope with a par cular set of process chemistry, it would be necessary to double up on piping, pumps, valves etc., to allow each chemical to be handled through an individual set of pipework, with the addi onal costs associated with such a set-up, thus increasing manufacturing costs and reducing efficiency. This would make EU produc on uneconomic and could result in produc on being moved to non-EU based factories. What has been said thus far is generic and covers a wide range of uses for fluoropolymer lined piping. What follows are a couple of specific examples of uses where there are no suitable alterna ve materials: Produc on of electronic chips - requiring High Purity Acid: The etching of microchips in the electronic industry requires high purity (sulfuric and hydrofluoric) acids with less than 36ppt (parts per trillion) contamina on. As the circuits on the chips get smaller, so the purity of acid required gets higher. The only pipework suitable to handle these acids and maintain the purity required are fluoropolymer lined pipework. If fluoropolymers were to be banned, then electronic chip & computer manufacture is unlikely to be sustainable within the EU compared to manufacturing in other countries. Process: The normal "dirty" acid which is available a er the standard acid produc on process needs to be refined by evapora on followed by absorp on/condensing. This process runs at around 150C and requires corrosion resistant material of construc on. Glass or glass lined steel cannot be used, because the acids leach out chemical elements from the glass (glass lining) which are harmful to the electronic circuits on the electronic chips. Exo c metal lining (including tantalum) cannot be used either, because metal ions they release would generate short circuits in the electronic chips a er etching. Other plas cs are clearly not temperature or chemical resistant enough for this applica on. Produc on of Toluene Diisocyanate (TDI) and Methylene diphenyl diisocyanate (MDI) for Polyurethane produc on: Polyurethane is a common base material for many things including advanced glues used in products such as light weight high tech designs like cars, airplanes and buildings, as well as in the manufacture of high-performance insula on. Process: 3 Manufacturing polyurethane is a highly corrosive process running at temperatures between 100 and 150C. Here glass lined steel pipework is used for the chemical reac on and transporta on for these highly corrosive chemicals. However, this `stress sensi ve' material needs expansion joints and bellows made from a material able to withstand the chemicals and temperatures used to prevent cracks in the pipework and vessels. PTFE is used to manufacture such bellows and maintain the cleanliness criteria needed. Any materials other than PTFE, such as rubber, would not survive more than a few months in this applica on, while PTFE bellows have a life me of around ten years. Informa on on benefits Due to the proper es, uses and importance of PTFE / PFA fluoropolymers we can see no benefit to the inclusion of such fluoropolymers in the scope of Annex XV. Other socio-economic analysis (SEA) issues If PTFE / PFA fluoropolymers were to be included in the scope of Annex XV as proposed, there are several foreseeable consequences: Our business would not be able to con nue selling PTFE / PFA fluoropolymer lined pipework and valves and as this cons tutes 95% of our sales then the business would not be able to con nue resul ng in the loss of 70+ direct jobs plus as at least that many again in the local economy as sub-suppliers. In the UK there are over 700 businesses that manufacture pharmaceu cal and chemical products. Their combined turnover is almost 10 billion, employing over 136,000 people3. In Europe, there are over 2,100 businesses that manufacture pharmaceu cal products. Their combined turnover is almost 300 billion, employing approximately 840,000 people4, almost all of which use PTFE / PFA fluoropolymer lined pipework and fiUngs in one form or another. If the cost of produc on of such products increases significantly then the `a;rac veness' of Europe (and the UK) as a pharmaceu cal and chemical manufacturing centre will reduce resul ng in plant closures as they migrate to cheaper loca ons. The size of any socioeconomic impact of such a ban is difficult to es mate but given intense commercial pressure under which these companies operate, the impact will be significant and detrimental. Having to replace PTFE / PFA fluoropolymer lined pipework with less effec ve alterna ves, where this is even possible, will result in less reliable process plant. This in turn will lead to more failures/leaks, leading to more damage to the surrounding equipment, more poten al for leaks of hazardous chemicals into the environment, more poten al injuries to personnel, more repair/rec fica on costs. Also, the replacement process pipework will have shorter life mes, leading to higher costs due to increased maintenance costs, more frequent replacement of equipment, the increased use of scarce resources to produce replacement parts, and addi onal disposal costs of the scrap products. 3 Reference: Sta s ca - Pharmaceu cal industry in the United Kingdom (UK) - Sta s cs & Facts h;ps://www.sta sta.com/topics/5056/pharmaceu cal-industry-in-the-uk/ 4 Reference: Sta s ca - Pharmaceu cal industry in Europe - Sta s cs & Facts, h;ps://www.sta sta.com/topics/8631/pharmaceu cal-industry-in-europe/#topicOverview 4 Transi onal period Given the current lack of suitable alterna ves to PTFE / PFA fluoropolymers it is not appropriate to implement a ban in any form on these substances as used in lined pipework and associated equipment. The restric ons it would place on cri cal industries and the impact of their movement of produc on centres to non-European loca ons would be catastrophic both in economic and social terms. The industries that would be affected by such a ban (even over an extended period) are key to the success of any Western economy and cri cal to the wellbeing and standard of living for its ci zens. On that basis it is suggested that a transi onal period would not be appropriate for PTFE / PFA fluoropolymer pipe lined products at least un l a commercially viable alterna ve has been iden fied. Request for exemp on In conclusion to the informa on provided above, PTFE / PFA fluoropolymers are polymers of low concern. Their proper es are completely different from many of the other PFAS molecules that the current restric on proposal is designed to ban. It is therefore requested that they be excluded from the current restric on proposal, since to include them would create massive unintended consequences for both industry and wider society within the EU. 5