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The two new restrictions are supplementary to the long-standing bans of lead, cadmium, mercury, and hexavalent chromium in packaging.

Unevaluated changes create the potential for negative impacts to the final pharmaceutical product (affecting the product's qualified identity, strength, quality, purity, or potency), which can lead to injury or even death of patients taking the MP.

It represents an opportunity for the U.S. to lead the world in stronger, more resilient, and sustainable manufacturing.

Page 4 of 5 INSPECTION REPORT CERTIFICATION: This is to certify that I, Bob Hales, was the lead inspector at this facility and that I have verified the accuracy of the observations in this inspection report: __________________________________________________________ Inspector Signature __________________________________________________________ RMP Coordinator/Approval __________________________________________________________ EPCRA Coordinator/Approval __________________________________________________________ Land Enforcement Section Chief/Approval Page 5 of 5

Drinking water containing these byproducts in excess of the MCL may lead to adverse health effects, liver or kidney problems, or nervous system effects, and may lead to an increased risk of getting cancer.* What should I do?

The effluent passes over a weir prior to discharge to the pipe leading to the receiving stream/ditch.

EPA Reddy Ice Reddy Ice Reddy Ice Reddy Ice Reddy Ice Reddy Ice EPA Lead Inspector Signature/Date Supervisor, ECDSC Signature/Date 6ENFORM-019-R8.2 (02/12/2020) Digitally signed by BLAKE BLAKE SIEMINSKI SIEMINSKI Date: 2024.08.19 10:05:59 -05'00' Blake Sieminski Digitally signed by SAMUEL SAMUEL TATES TATES Date: 2024.08.19 12:01:11 -05'00' Samuel Tates Date Date 1 Reddy Ice Dallas Inspection Dates: 06/18/2024 - 06/20/2024 Section I - INTRODUCTION PURPOSE OF THE INSPECTON I, Blake Sieminski and Kristen Latiolais, the Environmental Protection Agency (EPA) Region 6 inspectors arrived at the Reddy Ice Dallas Plant at approximately 9:00 a.m. on May 21, 2024, for an announced inspection.

We would welcome a full exemption of the empty space ratio requirements for transport packaging for clinical trials, as not providing such exemption could lead to a hard stop on the research of medicines in the EU.

The hinatvegntnioncorftahe PrEeASidn fof tnhe PtEAhdeafaiNniton'sanndtCtooenxapnantdcthresPAcSomupnoivuenrdsse,rboumtntecocmhpermeichaelrsriavceiynreeflpecotnt + oTfhveiteewrman`dPisSeaSsiilsy.ibmrpoleamde,ngteanbelreaf,onrodrisstpienlgufiischitnegrbm,etwwiecenhPdFoAcSsnsoatndinnfoonr-mPwFhAeSts,hearlsocboymnpoon-uenxdpesrtsh.armfulornat, but only communicates that the compounds under this term share the same trait for having a fully fluorinated methyl or Tmohneedthdvyeolcleiansmieaocrnaytroabcobtnrioomnaosdi.eetny.t"he defini. snot comncted to decions onHow FASs shodbegrouped in regulatory * s[nOdECpDrRaepcoartGuRiedcaonncienPgETASeCrenmtiranloolfogthyeUnivers of Pr. and pfctl Substances Recommendations efpia SFC PFAS Risk vs Benefit * Riskthough PAAS Use + Substances with intrinsic harmful propeties 4 persistent and ls obleou, endocrine diupting or CMI In AP, beinga PEAS notdoesnot determine persistance or bosccumulativeproprtes + Emissioonsf PEAS in Production, during Use or Endof Produet Life Pra Usewhere Risks areContralied + Proucs sujet toregulaotthieortnhasn REACH such a pharmaceuticals o animalhaltproducts, wheredata Is valablean sey emiriosk anssmesseetsnwretconaduclted + Prouction and manufcturing materials that donot become product component, such as foropolymers in Industrial use + Materials where emisions re propery controlled ver the fll fe cee which may nce production materials, butalo other macohraviiatinoneequirpmeynt efpia SFC Substitution Replacing chemicalwith safe alternative s Just oneway of lookin at substitution + More often, basic innovationphases ut harmful chemicals or othr hazards + Restricting substances based on structure, regarofdprlopeerstiess and/or ris, severely impacts R&D in all technology sectors RIimspklosioxnrays Lead HiVoglhtage Heawy neficnt CCirculhoa Hg (+10) Pras sMeonissittuirvee Lifetime ar wr ote efpia SFC Conclusion: What To Look For in a Simple, Applicable and Efficient Restriction + include + proportional measures addressithneg problem emisosfhiaromfnul substancestothe environment + Creat deni, HarmulprAS" + Derogations for demonstrated low/controlled emissionofs PFAS over the full Life Cycle + Essential Use derogtions on acaseby-case basi a a lat resort + exude + Undefined terminology an avoidable complet, leading to unceiritmpalemienntattioyn.

N/A SECTION A: Data System Coding MO/DAY/YR Inspection-Type Lead Inspector 2/24/2022 ROS (Reconnaissance David Phillips without Sampling) Facility-Type Unpermitted Industry SECTION B: Basic Field Data Name and Location of Facility Inspected: Entry Date/Time: Permit Effective (For industrial users, add recipient's NPDES permit number) 2/24/2022 9:26 AM Date: N/A UPL NA Inc.

Provide an update on the decommissioning of the piping leading from the sump to the small holding tank.

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY REGION 8 RESOURCE CONSERVATION AND RECOVERY ACT BASIC INFORMATION Facility Name: Calpet - La Barge COWDF Facility Location: 42.393747, -110.273988 RCRA ID: WYR000204065 Notification Status: Non-notifier Facility Contacts: Colton Ellingford, 307- 679-5804 Date of Inspection: May 16, 2023 Lead Inspector: Annette Maxwell Arrival Time: 12:15 p.m.

In this case, longer transition periods, such as those applied to the parameter lead in the new EU Drinking Water Directive, would have to be used to develop practical, climateand environmentally-friendly treatment processes, which could then be transferred to actual practical operation over the necessary planning and approval periods.

On December 19, 2023, I collected grab samples from the 5-stage drainage channel leading to Outfall 001.