Document b5gzeN4QovJM7yVdOQaa5Qj0D

General Comments: IDEX Health & Science is a global supplier of critical components, subsystems, and optics to, among others, the Analytical chemistry instrumentation industry. As an ISO 9001 certified supplier to all manufacturers of such instrumentation, we provide processed PFAS in many forms from valves through optics, tubing and fittings critical to the performance of laboratory instrumentation. These instruments in turn are used in chemistry laboratories worldwide which variously subscribe to ISO/IED 17025, ISO 9001, ISO 15189 and principles of Good Laboratory practice (GLP). Figure 1 Applications of PFAS in Laboratory Instrumentation Among the critical functions which PFAS components provided by IDEX Health & Science supplies worldwide is "In-line degassing" variously known as "degassing" or "deaeration" which is used to remove dissolved air from solvents and reagents as they move from reagent containers through analytical systems such as HPLCs. Degassing is critical to the performance of liquid chromatographic systems (LC or HPLC systems) and has a long history beginning in the 1970s culminating in the development of Fluoropolymer membranes for in-line degassing in the 1990s. The use of PFAS (polytetrafluoroethylene) hollow fibers gave way in 2000 to the use of an amorphous fluoropolymer (Chemours Teflon AF) as the primary means of removing gas from HPLC mobile phases using a vacuum - membrane - mobile phase arrangement. Prior to fluoropolymer membrane in-line degassing, instrument operators struggled with removing dissolved gas from HPLC mobile phases which negatively affected the performance of HPLC instrumentation. Prior to on-line PFAS based in-line degassing, mobile phases were heated, ultrasonically treated, sparged with nitrogen and lastly sparged with Helium to remove dissolved atmospheric gasses. Until degassing for HPLC became in-line using PFAS-containing membranes, reproducibility of HPLC analyses suffered, Laboratory scientist safety was compromised, and Chromatographic analysis accuracy and reproducibility were affected by the degassing method chosen. The history of development of automated systems for all types of chemistry has been driven by the development of materials used to control and process the broad types of liquids and mixtures necessary for synthesis and/or analysis. PFAS and PFAS blends have enabled instrument manufacturers and others from having concerns regarding the interaction between the instrumentation and analytes or with synthesis precursors. The use of PFAS contained within articles such as seals, valves, tubes, membranes, filters to name a few, has made it possible to engineer laboratory instruments fit for all chemistries thus saving costs associated with laboratory personnel creating their own single purpose instrumentation inert to specific targeted chemistries. The dossier submitters state that a move away from using fluoropolymers to alternative materials in many applications can be made. Our view is that there are no alternatives that can deliver the same combination of functionality and performance in laboratory instrumentation where fluoropolymers are now used. In spite of fluoropolymer's inherent higher cost over other polymers, instrument manufacturers have chosen to use fluoropolymers and custom blends of fluoropolymers because of their performance characteristics. This forms the first part of the quality foursome, DQ (Design Qualification). Following DQ, IQ (installation quality), OQ (operation quality) and PV (performance verification) are parts of Good Laboratory Practice (GLP). Important to GLP, the use of PFAS polymers in the laboratory environment has ensured samples do not interact with the materials which they contact ensuring accurate, sensitive analysis of all types of analytes. Specifically addressing the Dossier's need for instrumentation used to analyze samples for PFAS: We find in the Annex XV Restriction Report (Proposal for a restriction (PFAS) of 07/02/2023) that the very broad interpretation in the proposal for restriction, (PFAS), has omitted laboratory instrumentation as a category. Laboratory instrumentation for Chemical, Biochemical, Medical, Industrial, Wastewater, and in fact all types of laboratory instrumentation and sample handling consumables critically depend on PFAS of many types and forms for operation and accuracy (of which neat PFAS polymers, polymer blends, lubricants, processing aids, filters, membranes, and coatings are examples). However, clearly from statements made by the committee both in video presentations and documented as analytical techniques, the role of instrumentation in the regulation of PFAS has been recognized (Annex E Table E.170, E.171 Annex E to Annex XV Restriction Report) but provision for permanent exemption (derogation) has not been addressed, only a 13 year derogation. Additionally, the described laboratory instrumentation (GC, LC, MS) only comprises a small number of the types of instrumentation critical to human health, environmental health etc. An example that the instrumentation list is incomplete can be found in the new methods using Combustion Ion Chromatography noted in Answer to Specific Information Request 10 in this document. Ion chromatography also depends on the use of in-line degassing. We also must address the availability of repair components for laboratory instrumentation. Laboratory instrumentation used in regulated industries such as drug manufacture, drug quality assurance, environmental laboratories and more are subject to several testing protocols to ensure the instruments operate as designed (Design Qualification by the manufacturer, DQ). Instrument Qualification in the laboratory (IQ), Operational Qualification (OQ) and are then followed by Performance Qualification (PQ) which GLP requires to be documented as System Suitability verification. One of many on-line references to these requirements can be found at Understanding Analytical Instrument Qualification and Validation (complianceonline.com). Since PFAS are used in critical tubing, coatings, seals, valves and other areas in instrumentation and in the laboratory itself, substitutions of non-PFAS components into critical areas of instrumentation must start with the design (DQ) passing through all other stages which would necessitate requalification of the repaired instrument with an unknown outcome. We firmly believe that the proposed restriction stemmed from general concerns about some non-polymeric PFAS toxic effects on humans, in combination with their potential to bioaccumulate, to be persistent and/or mobile in the environment. It is therefore imperative for the European authorities to restrict the usage of these substances to protect the citizen's health and the environment. At the same time, it is our belief that the restriction proposal fails to differentiate polymeric PFAS that, due to their inherently high molecular weight, are neither bioavailable (they can't diffuse through the membranes cells and therefore cannot bioaccumulate) nor water soluble nor mobile in the environment nor toxic / ecotoxic. The criteria by which Polymers of Low Concern are judged may be found in Table 2 of "A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers" . https://doi.org/10.1002/ieam.4035 Additional information can be found in "A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers". https://doi.org/10.1002/ieam.4646 Additionally, most fluoropolymers are classified as Polymers of Low Concern (PLC) according to the OECD definition. Greater harm to citizen's health and the environment will result from restricting the use of polymeric PFAS in laboratories devoted to the overall health and well-being of humanity. https://www.americanchemistry.com/chemistry-in-america/news-trends/press-release/2022/new-studydemonstrates-vast-majority-of-commercial-fluoropolymers-meet-criteria-for-polymers-of-low-concerndesignation As mentioned above, most fluoropolymers are biocompatible; for this reason, a wide range of fluoropolymer-based articles has been used for decades in medical devices and in implantable devices thus intrinsically disputing the conclusion that fluoropolymer PFAS pose unacceptable risks to human health. We strongly believe that the restriction proposal should differentiate between the various types of PFAS based on their chemical composition and toxicological profile, manufacturing method and their particular uses. All PFAS are not the same and we therefore believe that a "one size fits all" regulation is simply too broad. Thus, we believe that a total ban on fluoropolymers is not proportionate. Given their benign hazard profile, an unlimited general derogation / exemption for laboratory applications of fluoropolymers should be provided in the proposal. Together with the derogation for the polymers, a derogation for all the needed intermediates (fluorinated monomers, fluorinated chain transfer agents, fluorinated cross-linking agents, etc.) should be granted to allow manufacturing of the derogated polymers. This is not taken into consideration in the current restriction proposal and is a serious contradiction that needs to be resolved before the entry into force. Additionally, the proposal allows for some specific time limited derogations for fluoropolymers, but it fails to make provision for their manufacturing by derogating the necessary ingredients for the manufacturing of said fluoropolymers. Much of our response as to the impact of a ban on fluoropolymers within the analytical and life science laboratory worldwide is derived from the SDI Global Assessment Report, 2022: The Laboratory Analytical & Life Science Instrumentation Industry, 2022 Strategic Directions International, part of Science and Medicine Group www.strategicdirections.com Additional information regarding specific PFAS polymers and solvents will be addressed in a confidential attachment. Answer to specific info request 1: IDEX Health & Science is a re-processor and user of various fluoropolymers for devices and subsystems used in Diagnostic Laboratory testing equipment, chemical synthesis and sequencing instrumentation. However, a diagnostic laboratory as referred to in Table E.171 is not the only place that laboratory instruments are used. The Strategic Directions International Report of 2022 (SDI report, www.strategic-directions.com) contains the scope of the uses for all instruments referred to in Table E.171 as well as many other critical uses which directly affect the quality of life for humanity. The SDI report includes the worldwide deployment of the following categories impacted by Annex XV PFAS regulation / restriction / elimination. The following categories contained within the SDI report clearly demonstrate the scope of Laboratory Analytical technologies critical to human health, environmental health and research and development. The SDI laboratory analytical technologies are as follows: Chromatography, Mass Spectrometry, Atomic Spectroscopy, Molecular Spectroscopy, Life Science Instrumentation, Surface Science, Materials Characterization, Lab Automation & Informatics, Sample Preparation Techniques, and Lab Equipment. (figure 1) The above categories including Analytical and Life Science instrumentation do not exist within Annex XV restriction report Table 9. These instruments, their critical nature and scientific and public health impact is also documented in the SDI report and should be included by reference in Annex XV and receive permanent derogation. Furthermore, some of the instruments in the SDI report as noted in Annex XV Annex E Table E.171 are critical in monitoring compliance with the proposed ban or limit on PFAS. Further investigations into PFAS effects on human health will necessarily rely on laboratory instrumentation of many different types. The instruments referred to within the SDI report have improved or even been created over decades of development in which sample sizes have been reduced and detection limits improved to where a single cell or single molecule can be detected. In nearly every instance, these improvements include the use of PFAS, PFA blends and proper deployment of seals, membranes and the like in sample critical contact areas. Some of the PFAS and their applications are referred to in part in Annex XV Annex A Table A.101 and some are omitted as described in Table 1 of this response. Contact: Eric Beemer, Director of Engineering, IDEX Health & Science @idexcorp.conn