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2023 PQRI Comments to ECHA REACH on Annex XV Restriction Report for Per- and polyfluoroalkyl substances (PFAS) About PQRI The Product Quality Research Institute (PQRI) (www.pqri.org) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality, manufacturing, and regulation. 0 PQRI Comments on Annex XV Restricon Report Contents Glossary............................................................................................................................................................................2 Introducon .....................................................................................................................................................................4 Background - Medicinal product lifecycle ....................................................................................................................4 Scope of Evaluaon ......................................................................................................................................................5 Summary of Core Findings............................................................................................................................................6 ECHA Specific Informaon Requests.................................................................................................................................7 Request #1 Sectors and Sub-uses .................................................................................................................................7 Request #1 Summary - Sectors and Sub-uses.............................................................................................................13 Risk to supply of medicines in EU ...........................................................................................................................13 Regulatory Challenges ............................................................................................................................................13 Pandemic and Catastrophic Event Preparedness ....................................................................................................14 Future populaon...................................................................................................................................................14 Aging populaon ....................................................................................................................................................14 Societal Impact and Unintended Consequences .....................................................................................................15 Request #2 Emissions in the end-of-life phase - manufacture, use, end-of-life..........................................................15 Request #2 Summary - Emissions in the end-of-life phase - manufacture, use, end-of-life........................................18 Request #3 Emissions in the end-of-life phase - incineraon effecveness................................................................18 Request #4 Impacts on the recycling industry ............................................................................................................18 Request #5 Proposed derogaons - Tonnage and emissions......................................................................................18 Request #6 Missing uses - Analysis of alternaves and socio-economic analysis.......................................................18 Defining PFAS: Grouping, Properes and Hazard Assessment ................................................................................18 PFAS in the Pharmaceucal Supply Chain...............................................................................................................20 Raonale for Pharmaceucal Sector PFAS Usage and Sub-uses..............................................................................23 PFAS Used to Produce and Deliver Medicinal Products Alternave Potenal.........................................................29 Request #6 Summary Missing Uses Alternaves and substuon consideraons......................................................34 Request #7 Potenal derogaons marked for reconsideraon-Analysis of alternaves and socio-economic analysis. ...................................................................................................................................................................................34 Request #7 Summary - Potenal derogaons marked for reconsideraon current derogaons not feasible. ...........36 Request #8 Other idenfied uses - Analysis of alternaves and socio-economic analysis..........................................37 Request #8 Summary - Other idenfied uses Societal Cost of Ban for Pharma ..........................................................43 Request #9 - Degradaon potenal of specific PFAS sub-groups................................................................................43 Request #10 - Analycal methods..............................................................................................................................43 Closing Remarks: Bringing back points to consider and paent impact..........................................................................43 References......................................................................................................................................................................46 1 PQRI Comments on Annex XV Restricon Report Glossary AD API CCS COPD CSS DDS EC ECHA ECTFE EEA EiF EMA EPPA SEA ETFE EU FEP FFKM FIH FKM FVQM GMP HVAC IMPD IND IPAC IPAC-RS MAA Mab Mfg OECD OELs PFAS PFOA PLC pMDI PMT POC PPE PQRI PTFE PVDF QC R&D Alzheimer's Disease Acve Pharmaceucal Ingredient Container closure system Chronic Obstrucve Pulmonary Disease European Commission Chemicals Strategy for Sustainability Drug delivery system European Community European chemicals agency Ethylenechlorotrifluoroethylene European Economic Area Entry into Force European Medicines Agency European Public Policy Advisors Socioeconomic Analysis Ethylene tetrafluoroethylene European Union Fluorinated ethylene propylene Perfluoroelastomers First In Human Fluoroelastomers Fluorosilicones Good Manufacturing Pracce Heang, Venlaon, Air Condioning, Refrigeraon Invesgaonal Medicinal Product Dossier Invesgaonal New Drug Internaonal Pharmaceucal Aerosol Consorum Internaonal Pharmaceucal Aerosol Consorum on Regulaon & Science Markeng Authorisaon Applicaon Monoclonal Anbodies Manufacturing Organisaon for Economic Co-operaon and Development Occupaonal Exposure Limits Per- and Polyfluoroalkyl substances Perfluorooctanoic Acid Polymers of Low Concern pressurized Metered Dose Inhaler Persistant, mobile, toxic Proof of Concept Personal Protecve Equipment Product Quality Research Instute Polytetrafluoroethylene Polyvinylidene fluoride Quality Control Research and Development 2 PQRI Comments on Annex XV Restricon Report REACH Registraon, Evaluaon, Authorizaon and Restricon of Chemicals RO1 Restricon opon 1 in Annex XV Restricon Report on PFAS RO2 Restricon opon 2 in Annex XV Restricon Report on PFAS SBT Science-Based Targets SBTi Science-Based Targets iniaves TULAC Texles, Upholstery, Leather, Apparel and Carpets UK United Kingdom 3 PQRI Comments on Annex XV Restricon Report Introducon The Competent Authories of Germany, The Netherlands, Sweden, Denmark, and Norway submited a joint REACH Annex XV restricon proposal for a broad group of PFAS.

BISPHENOL AF Consortium Initial input into public consultation on the restriction of BPA and Bisphenols of Similar Concern Brussels, 25 January,2023 The Bisphenol AF and related substances REACH registration Consortium groups the registrants of Bisphenol AF in Europe, both manufacturers and importers.

Draft agenda for PFAS-RESTRICTION WEBEX Meeting between DE, DK, NL, NO, SE CA and ECHA and COM 18 May, 9:00 - 13:00 (CET) Login details: See below Point 1 - Opening and adoption of the agenda (9:00-9:10 am) Point 2 - Minutes and action points (9:10 - 9:25 am) 2021-05-10_PFAS RESTR-16 Minutes and APs_Draft of FINAL.docx 2021-05-10_List of open APs.docx Point 3 - Status of COM/ECHA restriction on firefighting foams (9:25 - 9:40 am) - Update on collaboration with universal PFAS restriction (ECHA) Point 4 - Status update WP1 (09:40 - 09:50 am) - Comments received from COM and AT CA - Next steps Point 5 - Status update WP3 (09:50 - 10:10 am) - Feedback from discussion in PBT-EG (NO CA) - Hazard evaluation of alternatives (UBA) - Next steps for borderline documents (ENV and HH) Point 6 - Status update WP4 (10:10 - 10:40 pm) - Update from meeting on 12 May 2021 (Exposure and emission calculation) - 2nd round questionnaire (document to be circulated by ) Point 7 - Status update WP7 and Essential Use (10:40 - 10:45 am) Point 8 - Exchange of literature/references (10:45 - 11:00 pm) - Endnote library creation for dossier (see: PFAS Handling of literature.docx, circulated with this mail) Break 11:00 - 11:20 am Join by meeting number Meeting number (access code): Meeting password: 7nERmY2dyf3 (76376923 from phones and video systems) Tap to join from a mobile device (attendees only) ,1637174604#76376923# Germany Toll Some mobile devices may ask attendees to enter a numeric password.

RMOA CONCLUSION DOCUMENT _________________________________________________________________ Regulatory Management Option Analysis Conclusion Document Substance Name: EC Number: CAS Number: Per- and polyfluoroalkyl substances, PFAS - Authority: Date: Germany, the Netherlands, Sweden, Norway, Denmark June 2021 RMOA CONCLUSION DOCUMENT _________________________________________________________________ DISCLAIMER The author does not accept any liability with regard to the use that may be made of the information contained in this document.

Draft agenda for PFAS-RESTRICTION WEBEX Meeting between DE, DK, NL, NO, SE CA and ECHA and COM 18 May, 9:00 - 13:00 (CET) Login details: See below Point 1 - Opening and adoption of the agenda (9:00-9:10 am) Point 2 - Minutes and action points (9:10 - 9:25 am) 2021-05-10_PFAS RESTR-16 Minutes and APs_Draft of FINAL.docx 2021-05-10_List of open APs.docx Point 3 - Status of COM/ECHA restriction on firefighting foams (9:25 - 9:40 am) - Update on collaboration with universal PFAS restriction (ECHA) Point 4 - Status update WP1 (09:40 - 09:50 am) - Comments received from COM and AT CA - Next steps Point 5 - Status update WP3 (09:50 - 10:10 am) - Feedback from discussion in PBT-EG (NO CA) - Hazard evaluation of alternatives (UBA) - Next steps for borderline documents (ENV and HH) Point 6 - Status update WP4 (10:10 - 10:40 pm) - Update from meeting on 12 May 2021 (Exposure and emission calculation) - 2nd round questionnaire (document to be circulated by Point 7 - Status update WP7 and Essential Use (10:40 - 10:45 am) Point 8 - Exchange of literature/references (10:45 - 11:00 pm) - Endnote library creation for dossier (see: PFAS Handling of literature.docx, circulated with this mail) Break 11:00 - 11:20 am Join by meeting number Meeting number (access code): Meeting password: 7nERmY2dyf3 (76376923 from phones and video systems) Tap to join from a mobile device (attendees only) ,1637174604#76376923# Germany Toll Some mobile devices may ask attendees to enter a numeric password.

Eidgenssisches Departement fr Umwelt, Verkehr, Energie und Kommunikation UVEK Bundesamt fr Umwelt BAFU Sektion Altlasten PFAS - mterbergreifender Austausch 7.12.2020 / Sektion Altlasten, BAFU PFAS und Altlasten: Fallbeispiele der PFAS-Altlastenproblematik Brandbungspltze / Grossbrand Brandbungsplatz Lonza, VS: sehr hohe PFAS-Belastung (Boden und Grundwasser), erste grosse PFAS-Sanierung der CH: Material (ca. 45'000 m3) wird nach sterreich exportiert.

CERTIFIED MAIL RETURN RECEIPT REQUESTED September 9, 2024 ATTENTION: Jiete International Trading, Inc., 19042 San Jose Avenue, Unit Q Rowland Heights, CA 91748 Hongjian Li Registered Corporate Agent for Jiete Internation Trading, Inc. 108 N Ynez Avenue Monterey Park, CA 91754 Request for Information Under Sections 114(a)(1) and 208(a) of the Clean Air Act, h^ The United States Environmental Protection Agency ("EPA") hereby requires Jiete International Trading, Inc., and any of its parent organizations, affiliated organizations, predecessors, successors, or assignees, including but not limited to Tianjin Jiete Three-Way Vehicle Catalytic Converter Co., Ltd, (collectively "Jiete")1 to provide the information requested below.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY New England Regional Laboratory Laboratory Services and Applied Science Division 11 Technology Drive, North Chelmsford, MA 01863 Report Memorandum Drafted: Finalized: 09/08/2021 09/28/2021 Subject: From: Stack Emission Testing Observations - William Osbahr, Stack Testing Coordinator, /WAO/ Field Services Branch (FSB) Tyler Kotsifas, Stack Testing Coordinator (Trainee), FSB /TLK/ Through: Jerry Keefe, Investigations Team Leader, FSB /JCK/ To: Christine Sansevero, Chief, Air Compliance Section Enforcement and Compliance Assurance Division Facility Information: A.

Report Date: I.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 1 5 POST OFFICE SQUARE, SUITE 100 BOSTON, MASSACHUSETTS 02109-3912 Clean Air Act Inspection Report Drafted: September 28, 2022 Finalized: October 5, 2022 EPA Inspector: Tom McCusker, Environmental Engineer, Air Compliance Section /TTM/ EPA Reviewer: Darren Fortescue, Senior Enforcement Coordinator, Air Compliance Section /DEF/ Date of Inspection: September 22, 2022 Facility Name: Trelleborg Coated Systems US, Inc.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 1 Laboratory Services and Applied Science Division 11 Technology Drive North Chelmsford, Massachusetts 01863-2431 Drafted Date: Finalized Date: November 18, 2020 December 17, 2020 Subject: Reconnaissance and Sampling Inspection Report Clean Water Act - National Pollutant Discharge Elimination System City of Bridgeport, CT From: Michelle Coombs, Investigator Field Services Branch (FSB) Laboratory Services and Applied Science Division (LSASD) \MRC\ Reviewed By: Jerome Keefe, Investigations Team Leader, LSASD-FSB \JCK\ To: Denny Dart, Water Compliance Section Chief, Enforcement and Compliance Assurance Division (ECAD-EWC) CC: Alex Rosenberg, Inspector, ECAD-EWC I.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 1 Region 1 2 5 Post Office Square, Suite 100 3 BOSTON, MA 02114-2023 4 Dated via electronic signature stamp Tricia Haederle Sikorsky Aircraft Corporation 1210 South Avenue Bridgeport, CT 06604 RE: NOTICE OF VIOLATION of the Resource Conservation and Recovery Act Act of 1976 (RCRA), the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 U.S.C. 6622(a) and 6924(d) through (m), and Chapter 22a of the Connecticut General Statutes.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 10 1200 6TH AVENUE SEATTLE, WASHINGTON 98101 DATE: SUBJECT: FROM: THRU: TO: See date of Section Chief signature CLEAN AIR ACT INSPECTION REPORT Phillips 66 Portland Facility, Portland, Oregon Daniel Heins, Environmental Scientist Air Toxics Enforcement Section, EPA Region 10 Derrick Terada, Acting Section Chief Air Toxics Enforcement Section, EPA Region 10 File BASIC INFORMATION Facility Name: Phillips 66 Portland Facility Facility Location: 5528 NW Doane Avenue, Portland, OR 97210 Date of Inspection: June 21, 2022 EPA Inspector(s): 1.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 10 1200 6TH AVENUE SEATTLE, WASHINGTON 98101 DATE: SUBJECT: FROM: THRU: TO: See date of Section Chief signature CLEAN AIR ACT INSPECTION REPORT Republic Services Coffin Butte Landfill, Corvallis, OR Daniel Heins, Environmental Scientist Air Toxics Enforcement Section, EPA Region 10 Derrick Terada, Acting Section Chief Air Toxics Enforcement Section, EPA Region 10 File BASIC INFORMATION Facility Name: Republic Services Coffin Butte Landfill Facility Location: 28972 Coffin Butte Road, Corvallis, OR 97330 Date of Inspection: On Site Inspection: June 23, 2022 Virtual Conference: July 11, 2022 EPA Inspector(s): 1.