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Ref. Ares(2024)1733648 - 06/03/2024 Presentation Outline About Gore Gore Product Portfolio About Fluoropolymers Charles River Laboratories research Conclusions 2022 W. L. Gore & Associates 2 of 22 About Gore Privately held US company based in Newark/Delaware Founded more than 60 years ago by Bill and Vieve Gore More than 12,000 Associates globally and $4.5 billion in annual revenues In Europe around 2,000 Associates - Manufacturing facilities and sales offices in Germany and Scotland -Sales offices in a number of European countries. 2022 W. L. Gore & Associates 3 of 22 Gore`s product portfolio based on ,Fitness for use` Core Technology 2022 W. L. Gore & Associates Performance Solutions Division Improving the processing and delivery of pharmaceutical products Enabling the exploration of space for 50 years Pioneering the use of ePTFE for industrial filtration to control emissions Facilitating electrochemical conversion of a fuel cell to electrical energy with GORESELECT Membrane ices Protecting portable electronics, automotive components and enclosures Medical Products Division Improving patient outcomes with stent graft technology Advancing medicine with ePTFE cardiovascular and soft tissue repair patches Reducing bleeding and time to hemostasis through GORE-TEX Sutures Treating more than 300,000 aortic aneurysm patients with GORE EXCLUDER Devices Partnering with clinicians, more than 40 million medical devices implanted Fabrics Division Safeguarding firefighters from heat stress with GORE-TEX Moisture Barrier Protecting soldiers worldwide with GORE-TEX Fabrics Combining durable waterproofness with optimal breathability in GORE-TEX SURROUND Footwear Revolutionizing breathability with GORE-TEX ACTIVE Products with SHAKEDRYTM Product Technology Keeping workers safe with the lightest arc rated GORE-TEX PYRAD Products 4 of 22 GORE Fuel Cell Technologies Membrane electrode assemblies (MEAs) play a key role in the conversion of hydrogen to electrical energy. They consist of two electrodes (anode and cathode) on either side of a PTFE reinforced, ion-permeable polymer electrolyte membrane. Since 1994 Gore has developed: The GORE-SELECT membrane for proton exchange between the anode and cathode The GORE PRIMEA membrane electrode assembly (MEA) In addition to automotive applications, Gore's products are also being used in stationary, emergency power and energy storage systems 2022 W. L. Gore & Associates 5 of 22 GORE Mercury and SO2 Control System (GMCS) A passive sorbent system for capturing elemental and oxidized gas phase mercury from industrial flue gas. A fluoropolymer-based Sorbent Polymer Catalyst (SPC) composite material. Discrete stackable modules with an open channel structure which provides low pressure drop, avoiding the need for an additional booster fan. Modules will continuously capture mercury for many years without requiring any adjustment, regeneration, or replacement. They also provide an SO2 removal as cobenefit Mercury emissions reduction up to 80% possible Installed in coal-fired power plants in the EU to match the EU updated regulation : Germany: Chemnitz, Schkopau, Czech Republic: Mlnk and Prague; Poland: Belchatow and Patnow. 2022 W. L. Gore & Associates 6 of 22 GORE TAG Conformable Thoracic Stent Graft Partially Uncovered Stent helps achieve 360 wall apposition in angulated anatomy Radiopaque Gold Bands aid in accurate device positioning and visualization at patient follow-up Compression-resistant design maintains radial strength and achieves wall apposition in angulated arch anatomy Distributes point load and contributes to long-term durability in maximum oversizing conditions Sutureless Construction eliminates risk of graft failure from sutures ePTFE graft technology on luminal and abluminal surface Sealing Cuffs engineered to provide increased security against endoleaks Leverages more than 36 years of experience with ePTFE and a reliable platform with proven clinical durability and strength Low permeability with abrasion-resistant properties 2022 W. L. Gore & Associates 7 of 22 Weatherproof and flame-retardant GORE-TEX fabric arc rated 2022 W. L. Gore & Associates After ignition of the electric arc - 400 Alternating Voltage (AC) and 7 Kiloampere kA - in the test case, a hot plasma and gas cloud hits the jacket. 8 of 22 Overview Per- and Polyfluoroalkyl Substances (PFAS) 1 Group re [| 2categories Non-Polymers Polymers | 5 classes Perfluoroalkyl Substances reaoroniy ids|||/jeorramrpogoeunnscoefnoriwtciacrhboonlls Fi ron ProS, iProormbgroupe ave CPoomlpyofulnudosrfooralwkhyeln aSubstances. eo eos been replaced by fuorines 1 I, Caartesmoenldy r ay ws ad ETT S Totymerc Feuoraporeler > DeRes deity Jol) a Side-chain FluorinatedPolymers [_,_{PP ] ete a m= 34 | Overview Per- and Polyfluoroalkyl Substances (PFAS) QUSTIETTERZEN with a wide variety of properties 1fully uorinated carbon Pp o Liquids 0 [Solids Ee -- ---- Fluoropolymers -- Key properties Durability Inertness. Thermalstability Resistantcoe degradation ve Mechanical strength HH SeenennnnnI ewwwweyey Polymer Chemical/Physical Properties Predictive of Low Hazard wA a4d a 8~ nen awe GIG T o menos ee aw ~ ~~ Vo cohw wTeer"o pWe om mWenaEEeSx EbeSe oan Fluoropolymers with these properties have demonstrated low health and environmental hazard. Fluoropolymers with these low hazard properties are unique among the PFAS They are distinctly different from other polymeric and non-polymeric per- and polyfluoroalkyl substances (PFAS) They should be separated from other PFAS for risk assessment or regulatory purposes Their Physical, Chemical and Biological properties are predictive of low health and environmental hazard PFAS are vastly different -- one group for PFAS is not scientifically appropriate 2022 W. L. Gore & Associates 13 of 22 PTFE used in Gore products has very low levels of low molecular weight leachables PTFE is impervious to microbial degradation.* Fine powder PTFE has low levels of low molecular weight leachables including residual monomer, low molecular weight oligomers, etc.** PTFE has a long history of performance in a variety of applications that require highly stable, clean and chemically inert materials. Examples: implantable medical devices, pharmaceutical processing equipment, semiconductor manufacturing *King MW, Gupta BA, Guidoin R. 2013. Biotextiles as medical implants:15. Vascular prostheses for open surgery. Cambridge (UK): Woodhood. p 434-484; Charles River Labs studies. **See supplement to Henry et al., 2018, Integrated Environmental Assessment and Management, Vol. 17, No. 2, pp. 331-351. 2022 W. L. Gore & Associates 14 of 22 Background - PTFE fine powder g B: = Polytetrafluoroethylene (PTFE; CAS no. 9002-84-0) is a polymerof the monomer tetrafluoroethylene, TFE Granular . #5 : Fhe SN ERE Lk -Aqueous Dispersion Fine Powder (ASTM D4895) pm dor Pree ine powder = This presentation focuses on the PTFE fine powder, a polymer. = Many textbooks and peer-reviewed publications exist on the properties of PtTfnoFsEurctaionend suhroohpwohtemoersm:aMntautefra,icaTttuireoencaannddlAplpokraoiocynes,sds PtTbFyESd,a iEnbcelsiuod,iWnigka AnesfgiadSconce = bRyydoDakmsiangd oirepietar,dCchpatri3tnicmkitAsnpenctssofhFaisrhnated ganas and Polymers,inPntedomer: Volume ~ TFascienatincgoFfamPoupcaraypmoiytresrsao,nd2ToeEaktyoAnp,iceattGoenosrgsecDErtaay,, CdRaC srsu,n200A.mar and Sry For, Er, 2020, ITOo ri eminiuiarsecfaPa0plybomkermsa,aeSoSAAnA, Marolca Chars nd ris, Potential Routes of Exposure: Air, Water, Soil Environmental Partitioning: weIngestion, Dermal _ Inhalation, Ingestion, Dermal aroo Inhalation, Ingestion, Dermal Studies Performed at Independent 3rd Party Laboratory (Charles River Labs in Den Bosch, the Netherlands) + Standard protocols used (OECD Efate) + Performed under Good Laboratory Practices + Studies were performed oorn bosccomy atton, to provide consistent evidence that persistence of PTFE does not imply uerreesercacautnon,gi i nis roe fr ofran, + ~DaStEaTArCo,uLtiOneRlDySsh2a02r1e,dEamtersgcinegntCiofnitcammienaenttisngs as studies are finalized OECD Test Title Melting Point/Melting Range (OECD 102) Determination of the Number-Average Molecular Weight and the Molecular Weight Distribution of Polymers using Gel Permeation Chromatography (OECD 118) Status/Results The melting temperature of the test item was determined using differential scanning calorimetry (DSC). Melt transition observed at ~350C (662F); no further melting /decomposition below 400C. Supports thermal stability at environmentally relevant temperatures. PTFE was not sufficiently soluble to be evaluated by guideline using GPC even after sonication and stirring (19 hours) in representative solvents tetrahydrofuran, dichloromethane, dimethylformamide, and dimethylacetamide. Standard Specific Gravity (SSG) and Melt Flow Rate (MFR) are used to determine fluoropolymers MW rather than rheological and dynamic light scattering methods. By alternative methods, PTFE MW is >500,000 Da. Vapor Pressure (OECD 104) <1 x 10-10 mm Hg @ 20C by the isothermal thermogravimetric effusion method. Henry's Law Constant Water Solubility (OECD 105) Expert Statement; Henry's law constant (HLC) is a measure of the concentration of a chemical in air over its concentration in water. HLC reflects volatility and likelihood to partition to air from water. High HLC means likely to volatize and have long range transport. Low HLC substances tend to persist in water and may be adsorbed onto soil or sediment. PTFE was not soluble in water. Behavior in water system PTFE was not soluble in water. Adsorption - Desorption Using a Batch Equilibrium Method (OECD 106) Partition Coefficient (n-octanol/water): Shake Flask Method (OECD 107) Expert Statement Expert Statement; PTFE is not soluble in octanol or water. Therefore, no Partition Coefficient determination was possible. Partition Coefficient (n-Octanol/Water), High Performance Liquid Chromatography (HPLC) Method (OECD 117) Octanol-air partition coefficient (log Koa) Expert Statement; PTFE is not soluble in octanol or water. Therefore, no Partition Coefficient determination was possible. Expert Statement: PTFE is not soluble in octanol. Therefore, no Partition Coefficient determination was possible. 2022 W. L. Gore & Associates 17 of 22 OECD Test Title Hydrolysis as a Function of pH (OECD 111) Phototransformation of Chemicals in Water - Direct Photolysis (OECD 316) Phototransformation of Chemicals on Soil Surfaces (OECD draft document) Screening Test for Thermal Stability and Stability in Air (OECD 113) Ready Biodegradability (OECD 301B) Inherent Biodegradability OECD 302 C (METI) Biodegradation of organic chemicals in Aerobic Sewage Treatment (OECD 303A ) Biodegradability in Seawater (OECD 306) Study completed; awaiting report Status/Results Fine Powder PTFE should be considered completely photolytically stable. Analytical method development in design Stable at continuous processing temperature 260C and only 5% loss in weight at 549C (1020F). PTFE is considered stable at room temperature when no decomposition or chemical reaction is observed < 150C (302F). Not readily biodegradable. No inherent biodegradability Analytical method development in progress PTFE was not sufficiently soluble for evaluation by guideline even after sonication (15mins) and stirring (83mins). PTFE does not degrade in seawater. Aerobic and Anaerobic Transformation in Soil (OECD 307) Analytical method development in progress Aerobic and Anaerobic Transformation in Aquatic Sediment Systems (OECD 308) Analytical method development in progress 2022 W. L. Gore & Associates 18 of 22 CONCLUSIONS OF PTFE OECD CHEMICAL/PHYSICAL/STABILITY TESTING Air: Vapor pressure, thermal stability in air and thermal gravimetric analysis show low volatility or partitioning to air at <150 C. Stable at continuous use processing temperature of 260 C. The melting point results show stability at environmentally relevant temperatures. This data shows PTFE does not partition to air and is not subject to long-range transport via air. Water: PTFE is not dissolvable in water (OECD 105, 120). The lack of solubility in octanol or water (OECD 107, 117), prevented determination of octanol/air or octanol/water partition coefficients. This data shows the lack of mobility of PTFE, long-range transport in water, and impact via water solubility of PTFE on drinking water, plants and crops. Soil: Upon completion of analytical method development, OECD 307, 308, 106 and phototransformation on soil surfaces will be performed and results shared publicly. PTFE's extremely high molecular weight supports a lack of partitioning to soil. Biodegradation: PTFE was not readily (OECD 301B) or inherently (OECD 302C) biodegradable. Upon completion of analytical method development, OECD 303A and 307 will be performed and results shared publicly. PTFE is not biodegraded and not an ongoing source of substances of concern. Mobility is considered by ECHA to be a contributing factor for potential for long-range transport via air, water, drinking water contamination, uptake in plants and crops, and, degrading or otherwise producing additional undesirable persistent substances available for increased internal concentrations in biota as environmental exposures increase. The data presented here demonstrates the lack of PTFE mobility. 2022 W. L. Gore & Associates 19 of 22 Fluoropolymers Toxicity and Clinical Data PTFE, FEP, and a TFE/PAVE copolymer passed these GLP tests Cytotoxicity (MEM) (ISO 10993-5) Skin Sensitization (ISO 10993-10; OECD 406) Irritation (ISO 10993-10; OECD 406) Acute Systemic Toxicity 90-Day Subchronic Systemic Toxicity Two In Vitro + One In Vivo Genotoxicity 2- or 4-Week Implantation Hemocompatibility (ISO 10993-11; OECD 408) (ISO 10993-11; OECD 408) (ISO 10993-3; OECD 471, OECD 474, OECD 476) (ISO 10993-6) (ISO 10993-4; ASTM F756. ASTMF2382) Not Cytotoxic Non-Sensitizing Not Irritating Not Toxic Not Toxic Not Mutagenic No Significant Response Hemocompatible Note: 90-Day Subchronic Toxicity Studies included hematology, urinalysis, clinical chemistry, gross pathology, microscopic histopathology, organ weights, clinical observations. Histopathology performed on: ovaries, testes, brain, heart, liver, kidneys, spleen, thymus, adrenal glands, lymph nodes 45 years of patients receiving permanently implanted PTFE, FEP or TFE/PAVE copolymer cardiovascular medical devices demonstrate no chronic toxicity, carcinogenicity, reproductive, developmental or endocrine toxicity. 2022 W. L. Gore & Associates 20 of 22 Conclusions The OECD guideline data presented here on PTFE under environmentally relevant conditions supports: - PTFE does not partition to air, water or soil, nor lead to inhalation, oral or dermal exposures for biota, nor is it subject to long-range transport via air, water or soil - PTFE is not mobile and does not impact drinking water, plants or crops - PTFE is biotically/abiotically stable and not transformed to perfluoroalkyl acids (PFAAs) Published data, such as that in Henry et al., 2018 (which has been accepted by US, AP and EU medical device regulators) demonstrate that PTFE (fine powder meeting ASTM D4895) has a lack of: - low molecular weight oligomers, residual monomer and leachables - toxicity and bioaccumulation The stability, durability or persistence of fine powder PTFE enables "durable by design" products of high societal value (e.g., medical devices, wiring and cabling for satellites and aircraft, protective gear for hospital workers, spacesuits, cell phones, etc.). 2022 W. L. Gore & Associates 21 of 22 Questions: