Document OEj1KK00jzeOMM3YgDLrzjvnj

Bausch + Lomb PFAS Statement September 2023 Executive Summary: Bausch + Lomb is one of the world's largest suppliers of contact lenses, lens care products, eye health pharmaceuticals, intraocular lenses, and other eye surgery products. This response covers Bausch + Lomb's Surgical Product Portfolio which includes products used in both cataract and retina surgery. Bausch + Lomb's surgical division provides the tools and technologies to enable the use of innovative techniques for the treatment of cataract, corneal, refractive, vitreous and retinal eye conditions. Each year over 525,000 patients in the EU receive sight-saving treatment using an impacted Bausch + Lomb product. These products are the only viable option for these patients and without access to these, patients' eye health and eyesight would diminish impacting their quality of life and independence. Not receiving an unlimited derogation for these products would result in diminishing eye care for patients within the EU. The Annex XV report states that technically and economically feasible alternatives are not generally available for medical device implantable products, tubes and catheters, with high socio-economic cost to patientsi. The information presented in this statement today demonstrates that the amount of PFAS produced from ophthalmic surgical medical devices annually is in trace amounts and that no viable alternatives to PFAS for use with these products exist today. We are writing to ask that PFAS used in ophthalmic surgery medical devices including plastic illumination fibers, fluorinated lubricants, as well as perfluorocarbon liquids (PFCLs) and heavy silicone oil be exempt from the PFAS restriction currently being proposed to the ECHA branch of the European Union. 1. Sectors and (sub-)uses: Please specify the sectors and (sub-)uses to which your comment applies according to the sectors and (sub-)uses identified in the Annex XV restriction report (Table 9). If your comment applies to several sectors and (sub-)uses, please make sure to specify all of them. According to the annex XV report, Bausch + Lomb's endo-tamponade portfolio including perfluorocarbon liquids (PFCLs) and polydimethylsiloxane silicone oil are classified as ophthalmic implants and meet the classification of EN ISO 16672. Bausch + Lomb endo-illumination products as well as phacoemulsification and vitrectomy equipment and related consumables are medical devices used in ophthalmic surgery that have been omitted from consideration in the Annex XV report. Fluoropolymers possess unique combinations of material properties that make them attractive for use in both single-use and re-processable ophthalmic medical devices as well as in durable ophthalmic medical equipment products. Bausch + Lomb does not produce raw PFAS materials for use in surgical products. However, purchased PFAS containing components and machinable PFAS material stock are used in the production of B+L surgical products. The primary categories of B+L component materials known to contain a PFAS material in decreasing order of impact are: plastic illumination fibers under the tubes and catheter category of sectors and sub-uses in the Annex XV reportii, fluorinated lubricants, Teflon washers, Teflon tubing, PFCLs and heavy silicone oil. These categories currently impact sixty-nine products that are intended for long term distribution in the European Union under EU MDR 2017/745 regulation. In addition to these component materials already identified as containing PFAS, it is anticipated that the durable, Stellaris EliteTM Vision Enhancement System equipment product family may have additional PFAS contained within off-the-shelf, fluid power assembly components, such as pumps, regulators, valves, and filters. Similarly, the durable handpiece devices may have further PFAS impact from certain insulation materials used in the construction of autoclave re-processable, OEM electronic connections. An overview of the utilization of component materials by their primary category is as follows: Plastic Illumination Fibers: A microns thick fluoropolymer cladding sheath integrally applied over an acrylic core material in plastic optical fibers facilitates light transmission for illuminator products. These products provide intraocular illumination for visualization during posterior segment (retina) surgery. Six unique plastic illumination fibers of varying size and numerical aperture produce fifty different single-use products including: endo-illuminator probes (34 SKUs); illuminated laser probes (8 SKUs); chandeliers (6 SKUs); and infusion chandeliers (2 SKUs). Fluorinated Lubricants: Fluorinated Grease is applied to both single-use pneumatic vitreous cutter products and to re-sterilizable, ultrasonic phacoemulsification and lens fragmentation handpiece products. Pneumatic vitreous cutter products dissect and aspirate vitreous and tissue during posterior segment surgery. The fluorinated grease is applied between reciprocating parts of the cutting device to reduce friction and enable proper cutting action. Ultrasonic phacoemulsification handpieces and fragmentation handpieces leverage acoustic energy to dissect and extract the natural lens. Small amounts of fluorinated grease are applied to O-ring seals to enhance assembly of the transducer into the handpiece's outer housing and to enhance the sealing function of the Orings. PFCLs: Are used as a versatile medical device, helpful as a `third hand' to ophthalmologists during vitreoretinal surgery particularly during the management of retinal detachment complicated by proliferative vitreoretinopathy (PVR), giant retinal tears (GRT) or retinal detachment. The properties which make it desirable for intraoperative use are its clarity, a specific gravity of 1.7, a similar viscosity to saline, and a high vapor pressure. It is highly purified for medical application. They are used intraoperatively during surgery and are removed from a patient's eye at the end of surgery. Heavy Silicone Oil: Is used in retinal surgeries with moderate to severe retinal detachment, giant retinal tear, re-occurring retinal conditions and when air travel by a patient is necessary following surgery. The properties which make it desirable are its clarity, that it is non-expansile, its density of 0.98g/cm3 and refractive index of 1.40. They remain in a patient's eye following surgery and are removed during a second procedure at a future surgery date. A response and information specific to Bausch + Lomb's perfluorocarbon liquids and heavy silicone oil to the following questions are being submitted in a separate, joint industry statement. This separate statement is being submitted by Mtech Access directly, on behalf of Bausch + Lomb. 2. Emissions in the end-of-life phase: The environmental impact assessment does not cover emissions resulting from the end-of-life phase. To get a better understanding of the extent of the resulting underestimation, (sub-)use-specific information is requested on emissions across the different stages of the lifecycle of products, i.e. the manufacture phase, the use phase and the end-of-life phase. Please provide justifications for the representativeness of the provided information. In particular: a. Please provide, at the (sub-)use level, an indication of the share of emissions (as percentages) attributable to these three different stages. An indication of annual emission volumes in the end-oflife phase at sector or sub-sector level would also be appreciated. Illumination Fibers: Response For Sector = Medical Devices and Sub-Uses = Tubes and Catheters- Cladding Material Applied over Plastic Optical Fibers. Life Cycle emission volumes: (a.1) Bausch + Lomb Manufacturing Process Phase: We acquire spools of bulk plastic optical fibers produced by suppliers in the United States and Japan for use in our production of finished, single-use illumination products. We approximate that 5-10% of the purchased bulk fiber optic stock may be discarded as common landfill waste during the manufacture of the finished medical devices. This waste is generated in facilities located in the United States - primarily in the states of Missouri and Pennsylvania. We estimate that the collective annual volume of the PFAS cladding materials included in such US based manufacturing waste streams driven by products destined for the European Union is approximately 6000 cm3 per year. (a.2) Use Phase: The ophthalmic illumination product sector and its sub-uses involve only products provided for single surgical use, i.e., for a single medical procedure. Accordingly, there are no PFAS emitted during the usage phase. (a.3) End of Life Phase: At the conclusion of the ophthalmic medical procedure the illumination fibers have been exposed to potentially hazardous biological fluids due to the direct invasive contact with the patient's interior eye. They are thus discarded after use in accordance with facility practices concerning the removal of biohazardous surgical wastes. Commonly, incineration techniques are used by such hospital and related surgical facilities to dispose of such wastes. These waste streams generally terminate at the point of use. We estimate the total collective annual volume of PFAS cladding materials that enter the European Union in distributed ophthalmic illumination devices is approximately 0.06 m3. This quantity is minimally small in scale, comprising a cube that measures roughly 39 cm/side. A response and information specific to Bausch + Lomb's perfluorocarbon liquids and heavy silicone oil is being submitted in a separate, joint industry statement. This separate statement is being submitted by Mtech Access directly, on behalf of Bausch + Lomb. b. If possible, please provide for each (sub-)use what share of the waste (as percentages) is treated through incineration, landfilling and recycling. Please provide information to justify the estimates as well as information on the form of recycling referred to. Illumination Fibers: Response For Sector = Medical Devices and Sub-Uses = Tubes and Catheters- Cladding Material Applied over Plastic Optical Fibers. Incineration: We estimate that principally all (>99%) of PFAS waste products generated in the EU through end-of-life disposal of our finished, single-use ophthalmic illumination products are incinerated. The estimated solid mass of such material is approximately 131 kg/year. Landfilling: We estimate that less than 1% of finished illumination device products entering the EU may be scrapped by our customers or in our distribution center prior to their initial use and disposed of as non-biohazardous wastes in typical landfill streams. Recycling: None of the distributed single-use illumination devices with PFAS clad fibers is suitable for recycle at end of life. A response and information specific to Bausch + Lomb's perfluorocarbon liquids and heavy silicone oil is being submitted in a separate, joint industry statement. This separate statement is being submitted by Mtech Access directly, on behalf of Bausch + Lomb. 5. Proposed derogations - Tonnage and emissions: Paragraphs 5 and 6 of the proposed restriction entry text (see table starting on page 4 of the summary of the Annex XV restriction report) include several proposed derogations. For these proposed derogations, information is requested on the tonnage of PFAS used per year and the resulting emissions to the environment for the relevant use. Please provide justifications for the representativeness of the provided information. Despite the large number of impacted SKUs and the fact that 57 of the 69 are single-use products, the annual distribution of PFAS materials into the European Union is collectively very small. The following is an analysis by component category type of the annual PFAS emissions from B+L surgical products: Illumination Fibers: Response For Sector = Medical Devices and Sub-Uses = Tubes and Catheters- Cladding Material Applied over Plastic Optical Fibers. Plastic Illumination Fibers: Sales data for 50 individual products containing fiber optic materials was used to determine the annual volume and mass of PFAS materials which enter the EU presently. The collective volume of fluoropolymer cladding materials that enter the EU annually via B+L surgical products is estimated to fill only .060 m3 of space. For visualization purposes, this volume is represented by a cube measuring 0.39 meters per side. Using an estimated worst-case limit for the specific gravity of the fluoropolymer cladding, the corresponding annual mass of PFAS cladding materials distributed to the EU via B+L fiber optic surgical products is approximately 130.7 kg. (See Appendix A for details on data and methodologies used in this calculation). Given the very small annual contribution to the total PFAS waste stream that are driven by tubular optical claddings with surrounding plastic optical fibers, we are seeking a full unlimited derogation for this sector and sub-use. Methodology: Data Analysis Details The 50 established SKUs may be segmented into two high level families of products: pouched, Synergetics branded products (29 SKUs) and B+L branded, surgical pack products (21 SKUs). An itemized listing of the volume and mass of PFAS materials calculated to be contained in these products is provided for reference in Tables 6.1 and 6.2. Methodology Reference: The volume of PFAS cladding material entering the EU on an annual basis is estimated using a combination of design specifications and available sales data for the annual volume of devices (each) distributed to the EU. The calculation is as follows: VPFAS,EU = ACLAD,MAX*LMAX*QSALES-EU,MAX where: , = ; 2_-2_ 4 = ; -, = , 2021 2023 Note, sales data used in the calculation was provided in terms of boxes for single-use devices. Individual probe sales were determined by multiplying box sales by the quantity of devices per box. The mass of PFAS materials represented by the calculated volume of cladding distributed is then calculated by multiplying the distributed cladding volume by the cladding material density (specific gravity). The manufactured optical fiber material specifications only identify the cladding material as "fluoropolymer." However, a survey of common fluoropolymers (PFA, FEP, PTFE, TFM, ETFE, PCTFE, and PVDF) as published in the Matweb materials database indicates that a density of 2.17 g/cc is a reasonable worst-case estimate for the actual cladding density. A response and information specific to Bausch + Lomb's perfluorocarbon liquids and heavy silicone oil is being submitted in a separate, joint industry statement. This separate statement is being submitted by Mtech Access directly, on behalf of Bausch + Lomb. 6. Missing uses - Analysis of alternatives and socio-economic analysis: Several PFAS uses have not been covered in detail in the Annex XV restriction report (see uses highlighted in blue and orange in Table A.1 of Annex A of the Annex XV restriction report). In addition, some relevant uses may not have been identified yet. For such uses, specific information is requested on alternatives and socioeconomic impacts, covering the following elements: a. The annual tonnage and emissions (at sub-sector level) and type of PFAS associated with the relevant use. Same as Q2 & Q6 Fluoropolymer cladding over plastic optical fiber: Volume: 0.06 m3/year, Mass: 131 kg/year. b. The key functionalities provided by PFAS for the relevant use. Plastic Illumination Fibers: A microns thick fluoropolymer cladding sheath tube integrally applied over an acrylic core material in plastic optical fibers, similar to wire insulation. The PFAS cladding causes reflection of incident light due to differences in its numerical aperture relative to the core acrylic fiber and facilitates light transmission down the core fiber. This fiber optic material is used in single use, intraocular illumination products including endo-illuminators, chandeliers, illuminated laser probes, and illuminated infusion cannulas. These products provide intraocular illumination for visualization during posterior segment (retina) surgery. Six unique plastic illumination fibers of varying size (250 microns, 500 microns, and 750 microns) and numerical aperture produce fifty different single-use products including: endo-illuminator probes (34 SKUs); illuminated laser probes (8 SKUs); chandeliers (6 SKUs); and infusion chandeliers (2 SKUs). For reference, the typical fluoropolymer cladding thickness for these fibers is nominally between 7 and 12 microns. c. The number of companies in the sector estimated to be affected by the restriction. We anticipate widespread disruption to the supply of single use intra-ocular endo-illumination products for retina surgery amongst competing companies in the market. There are 13 companies in the endo-tamponade and vitrectomy equipment and related consumables sector that operate within the EU that we anticipate will be impacted by the restriction Similarly, there are 12 companies in the phacoemulsification equipment and related consumables sector that operate within the EU that we anticipate will be impacted by the restriction. Bausch + Lomb makes up approximately 11.4% of global revenue share in the surgical retina space1 and approximately 10.2% of global revenue in cataract surgery space2. Based on Bausch and Lomb's market 1 2023 Market Scope Retinal Surgical Device Market Report. Published March 2023. 2 2022 Market Scope Cataract Surgical Equipment Market Report. Published July 2022. share and our calculation of PFAS waste, we can reasonably calculate that the output of waste would be 10 times higher or approximately 1.37 metric tons annually. We do not have data concerning non-ophthalmic medical device usages of plastic optical fibers with PFAS cladding but would anticipate some impact to areas where endoscopic devices and other fiber optic imaging technologies are used. d. The availability, technical and economic feasibility, hazards and risks of alternatives for the relevant use, including information on the extent (in terms of market shares) to which alternative-based products are already offered on the EU market and whether any shortages in the supply of relevant alternatives are expected. Alternative fiber optic materials are available that use glass as a core material and hard polymer or silica materials for the cladding. Commercially available glass fiber optic materials are commonly used in our laser probe devices, and we understand their benefits and limitations. Laser products must use glass fibers because of the intensity of energy transmitted. Laser sources deliver light in a collimated fashion to the input side of the fiber optic transmission line. In contrast, ophthalmic illumination sources focus the light rays in a conical fashion into the input face of the fiber. Glass fibers with non-PFAS claddings are typically less than 400 microns in size with the most common size for laser probes being 150 microns. In contrast, the greatest volume of impacted illumination products use 500-micron PFAS fibers. Larger fibers are required at the illumination source interface to collect sufficient incident light energy to achieve the desired output intensity for visualization in the eye. While a larger diameter is required at the source end, a smaller diameter fiber is required at the patient side of the product to fit within metallic sheath tubes that are inserted into the patient's eye during surgery. State of the art surgical technology has now moved to sheath sizes as small as 27 gauge. Because the 500-micron plastic optical fiber is itself larger than the outer diameter of a sheath tube, it must be modified using special manufacturing techniques to fit within the sheath tube. Such processes are used to draw the plastic fiber optic material to the appropriate lumen size of the sheath tube and are not compatible with glass fiber alternatives. We have previously manufactured illuminated laser probe products and wide-field endo-illuminator products using glass fiber in lieu of PFAS-clad plastic optical fibers. In addition to significant material cost differences with these obsolete designs, these products suffered from much weaker light transmission. The difference in the amount of illumination delivered by glass-based alternative products has the potential to adversely affect the retina surgeon's ability to effectively visualize tissues during the surgical procedure relative to state-of-the-art product offerings. Further, while the cladding of such previously used glass materials did not contain PFAS, an outer buffer layer was commonly made from ETFE. e. For cases in which alternatives are not yet available, information on the status of R&D processes for finding suitable alternatives, including the extent of R&D initiatives in terms of time and/or financial investments, the likelihood of successful completion, the time expected to be required for substitution (including any relevant certification or regulatory approvals) and the major challenges encountered with alternatives which were considered but subsequently disregarded. We have contacted the manufacturers of our plastic optical fibers to determine if such PFAS-free alternatives are commercially available for evaluation. They have informed that no viable alternative, PFAS-free cladding products are available in their product offerings and that significant basic research and technology development would be required to develop such a product, presuming of course that it is scientifically feasible. Our current fiber manufacturers have further not indicated that any current R&D investments are taking place to develop non-PFAS claddings for plastic optical fibers. We do not currently engage in raw fiber optic material manufacturing and have little basis on which to estimate the time and financial investment required of a company to develop non-PFAS clad plastic optical fiber designs and the associated manufacturing processes. In the event a PFAS-free plastic optical fiber material could be developed and subsequently offered by our suppliers for viable alternative use in our medical device illumination products, significant investment in our own research and development would subsequently be required. Our initial feasibility research would involve testing to assess the functionality, biocompatibility, stability, sterilizability, and manufacturability of the alternative material in relation to the currently released baseline design. If initial feasibility testing demonstrated positive results, more thorough and extensive verification and validation testing of statistically significant quantities of products would be required along with considerable investment in manufacturing process development, scale-up, and qualification. Should the hypothetical viable alternative, PFAS-free fiber meet all such B+L design input requirements (driven by such sources as user needs, intended uses, standards, and risks), additional challenges associated with achieving global registration of associated design changes to the 50 or more saleable single use items would further ensue. As the fiber optic materials are all in direct, invasive patient contact, considerable registration review impact in terms of both time and expense would be anticipated. f. For cases in which substitution is technically and economically feasible but more time is required to substitute: i. the type and magnitude of costs (at company level and, if available, at sector level) associated with substitution (e.g., costs for new equipment or changes in operating costs); ii. The time required for completing the substitution process (including any relevant certification or regulatory approvals). iii. Information on possible differences in functionality and the consequences for downstream users and consumers (e.g., estimations of expected early replacement needs or expected additional energy consumption); iv. Information on the benefits for alternative providers. Viable alternatives for PFAS used in ophthalmic surgery medical devices including endo-illumination products, endo-tamponades as well as phacoemulsification and vitrectomy equipment and related consumables do not exist. g. For cases in which substitution is not technically or economically feasible, information on what the socio-economic impacts would be for companies, consumers, and other affected actors. If available, please provide the annual value of EU sales and profits of the relevant sector, and employment numbers for the sector. For retina surgery as a total industry, endo-tamponades, vitrectomy equipment and related consumables are estimated as a $1.28 billion USD market globally with Western Europe alone making up 28.2% of this, or $361 million USD3. In addition to this, in 2023 in Western Europe alone it is estimated that there will be 500 000 retina vitrectomy surgeries performed which will all require retina vitrectomy equipment, related consumables and liquid implants. For the cataract surgery equipment market, the global market is estimated at 1.79 billion USD with Western Europe alone making up almost 22% or $400 million USD of this4. In addition to this, in 2023 in Western Europe alone it is estimated that there will be 5.4 million cataract surgeries performed which will all require phacoemulsification equipment and related consumables. Annually Bausch + Lomb sells over one 185,000 endo-illumination products to hospitals and surgical centers within the EU. Similarly, Bausch + Lomb sells approximately 300 new phacoemulsification and vitrectomy systems annually in the EU a year, 4000 ultrasound handpieces and 340,000 equipment related consumables. This in turn means over 525,000 patients in the EU receive sight-saving treatment using an impacted Bausch + Lomb product each year. These products are the only viable option and without access to these, patients' eye health and eyesight would diminish impacting their quality of life and independence. Not receiving an unlimited derogation for these products would result in diminishing eye care for patients within the EU. 9. Degradation potential of specific PFAS sub-groups: A few specific PFAS sub-groups are excluded from the scope of the restriction proposal because of a combination of key structural elements for which it can be expected that they will ultimately mineralize in the environment. RAC would appreciate to receive any further information that may be available regarding the potential degradation pathways, kinetics or produced metabolites in relevant environmental conditions and compartments for trifluoromethoxy, trifluoromethyl amino- and difluoromethanedioxy-derivatives. Bausch + Lomb does not use any trifluoromethoxy, trifluoromethyl amino- or difluoromethanedioxy based PFAS in our products. i ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table 8. RO1 - Summary table of alternatives and cost impacts for PFAS manufacture and major PFAS use sectors resulting from a full ban of PFASs ii ANNEX XV RESTRICTION REPORT - Per- and polyfluoroalkyl substances (PFASs) Table 2. PFAS main applications and sub-uses 3 2023 Market Scope Retinal Surgical Device Market Report. Published March 2023. 4 2022 Market Scope Cataract Surgical Equipment Market Report. Published July 2022.