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HomeMy WebLinkAboutalamedamed-project2019-archive A Product Stewardship Plan For Unwanted Medicine from Households Alameda County, California February 15, 2019; Revised March 27, 2019 2 Table of Contents Introduction .................................................................................................................................................................. 6 Contact Information .................................................................................................................................................... 6 Plan Definitions ............................................................................................................................................................ 6 Unwanted Medicine ................................................................................................................................................... 8 Collection of Unwanted Medicine ........................................................................................................................... 8 A. Unwanted Medicine Collection Program .............................................................................................................. 8 1. Outreach ................................................................................................................................................................ 8 2. Implementation .................................................................................................................................................... 9 3. Convenience ......................................................................................................................................................... 9 4. Services .................................................................................................................................................................. 9 B. Kiosk Drop-Off Sites ................................................................................................................................................... 9 1. Kiosk Drop-Off Site Locations ........................................................................................................................ 10 2. Drop-Off Site Kiosk Placement and Maintenance Program .................................................................. 10 3. Kiosk Specifications .......................................................................................................................................... 10 4. Kiosk Collection .................................................................................................................................................. 11 a. Technician-Assisted Collection ............................................................................................................. 12 b. Host-Assisted Collection ......................................................................................................................... 12 5. Frequency of Pick-Up ....................................................................................................................................... 13 6. Procedures if a Kiosk is Full Prior to Scheduled Pick-Up ....................................................................... 13 7. Unplanned Event Preparedness ................................................................................................................... 14 C. Take-Back Events ...................................................................................................................................................... 14 1. Method.................................................................................................................................................................. 14 2. Procedures .......................................................................................................................................................... 15 D. Disposal of Unwanted Medicine from Kiosk Drop-Off Sites and Take-Back Events.............................. 15 E. Mail-Back Services for Unwanted Medicine ...................................................................................................... 16 1. Standard Mail-Back Services for Unwanted Medicine ............................................................................ 16 2. Inhaler Mail-Back Services for Inhalers ....................................................................................................... 17 3. Mail-Back Package Availability ...................................................................................................................... 17 4. Mail-Back Package Collection and Disposal ............................................................................................. 17 Plan and Collection Goals ....................................................................................................................................... 18 Patient Privacy ........................................................................................................................................................... 19 Call Center .................................................................................................................................................................. 19 Training ....................................................................................................................................................................... 19 A. Service Technician Training .................................................................................................................................. 20 Vendor, Transporter, and Disposal Facility Information .................................................................................... 21 Technician-Assisted Collection Kiosk Drop-Off Site and Take-Back Event Collection Services ..................... 21 A. Vendor for Technician-Assisted Collection Kiosk Drop-Off Sites and Take-Back Events .................... 21 B. Carrier for Technician-Assisted Collection Kiosk Drop-Off Sites and Take-Back Events ..................... 21 C. Reverse Distributor Facility & Transporters for Technician-Assisted Collection Kiosk Drop-Off Sites and Take-Back Events ............................................................................................................................................ 22 1. Reverse Distributor Facility ............................................................................................................................ 22 2. Transporter 1 ...................................................................................................................................................... 22 3. Transporter 2 ..................................................................................................................................................... 22 4. Transporter 3 ..................................................................................................................................................... 23 D. Disposal Facilities for Technician-Assisted Collection Kiosk Drop-Off Sites and Take-Back Events23 1. Disposal Facility 1 .............................................................................................................................................. 23 3 2. Disposal Facility 2 ............................................................................................................................................. 23 3. Disposal Facility 3 ............................................................................................................................................. 24 4. Disposal Facility 4 ............................................................................................................................................. 24 Host-Assisted Collection Kiosk Drop-Off Sites ...........................................................................................................24 E. Vendors for Host-Assisted Collection Kiosk Drop-Off Sites......................................................................... 24 1. Vendor 1 .............................................................................................................................................................. 24 2. Vendor 2 ............................................................................................................................................................. 24 F. Carrier for Host-Assisted Collection Kiosk Drop-Off Sites ............................................................................ 25 G. Reverse Distributor Facility & Transporter for Host-Assisted Collection Kiosk Drop-Off Sites .......... 25 1. Reverse Distributor Facility 1 ......................................................................................................................... 25 2. Reverse Distributor Facility 2 ........................................................................................................................ 25 3. Reverse Distributor Facility 3 ........................................................................................................................ 26 4. Transporter 1 ...................................................................................................................................................... 26 5. Transporter 2 ..................................................................................................................................................... 26 6. Transporter 3 ..................................................................................................................................................... 26 H. Disposal Facilities for Host-Assisted Collection Kiosk Drop-Off Sites ....................................................... 27 1. Disposal Facility 1 .............................................................................................................................................. 27 2. Disposal Facility 2 ............................................................................................................................................. 27 3. Disposal Facility 3 ............................................................................................................................................. 27 Standard Mail-Back Services ........................................................................................................................................ 28 I. Vendors for Standard Mail-Back Packages ...................................................................................................... 28 1. Vendor 1 .............................................................................................................................................................. 28 2. Vendor 2 ............................................................................................................................................................. 28 J. Carrier for Standard Mail-Back Packages .......................................................................................................... 28 K. Reverse Distributor Facilities and Transporter for Standard Mail-Back Packages ................................ 28 1. Reverse Distributor Facility ............................................................................................................................ 28 2. Transporter ......................................................................................................................................................... 29 L. Disposal Facilities for Standard Mail-Back Packages .................................................................................... 29 1. Disposal Facility 1 .............................................................................................................................................. 29 2. Disposal Facility 2 ............................................................................................................................................. 29 3. Disposal Facility 3 ............................................................................................................................................. 29 Inhaler Mail-Back Services ............................................................................................................................................. 30 M. Vendors for Inhaler Mail-Back Packages ........................................................................................................... 30 1. Vendor 1 .............................................................................................................................................................. 30 2. Vendor 2 ............................................................................................................................................................. 30 N. Carriers for Inhaler Mail-Back Packages ............................................................................................................ 30 1. Carrier 1 ................................................................................................................................................................ 30 2. Carrier 2 .............................................................................................................................................................. 30 O. Transfer Facility for Inhaler Mail-Back Packages .............................................................................................. 31 P. Transporter(s) for Inhaler Mail-Back Packages ................................................................................................. 31 1. Transporter 1 ....................................................................................................................................................... 31 2. Transporter 2 ...................................................................................................................................................... 31 Q. Disposal Facilities for Inhaler Mail-Back Packages .......................................................................................... 31 1. Disposal Facility 1 ............................................................................................................................................... 31 2. Disposal Facility 2 ............................................................................................................................................. 32 3. Disposal Facility 3 ............................................................................................................................................. 32 Unwanted Medicine Educational and Outreach Programming ....................................................................... 33 A. Overview ..................................................................................................................................................................... 33 4 B. Audiences ................................................................................................................................................................... 33 C. Messages .................................................................................................................................................................... 33 D. Tools/Communications Channels ........................................................................................................................ 34 1. Phone ................................................................................................................................................................... 34 2. MED-Project Website ....................................................................................................................................... 34 3. Materials .............................................................................................................................................................. 35 4. Social Media ....................................................................................................................................................... 35 5. Broadcast Outreach ......................................................................................................................................... 35 E. Collaboration with County Officials and Community Organizations .......................................................... 35 F. Effectiveness .............................................................................................................................................................. 35 G. Disclaimer ................................................................................................................................................................... 35 Compliance with Applicable Laws, Regulations, and other Legal Requirements ........................................36 A. DEA Controlled Substances Act and Implementing Regulations ............................................................... 36 1. DEA Registration Modification ...................................................................................................................... 37 B. United States Department of Transportation (DOT) ....................................................................................... 37 C. California Board of Pharmacy ............................................................................................................................... 37 Annual Report ............................................................................................................................................................ 37 Appendix A ........................................................................................................................................................................ 38 MED-Project Participants ................................................................................................................................................ 38 Appendix B ........................................................................................................................................................................39 Contact List for Outreach and Education to the Community ............................................................................... 39 Appendix C ....................................................................................................................................................................... 40 Interested Sites and Participating Kiosk Drop-Off Sites ........................................................................................ 40 Appendix D ........................................................................................................................................................................45 Potential Additional Kiosk Drop-Off Sites .................................................................................................................. 45 Appendix E.........................................................................................................................................................................53 Kiosk Mock-Up .................................................................................................................................................................. 53 Kiosk Signage .................................................................................................................................................................... 54 Kiosk Signage .................................................................................................................................................................... 55 Kiosk Signage .................................................................................................................................................................... 56 Appendix F ......................................................................................................................................................................... 57 Media List ............................................................................................................................................................................ 57 Appendix G ........................................................................................................................................................................64 MED-Project Request for Approval of Disposal Process for Host-Assisted Collection Kiosk Drop-Off Sites .............................................................................................................................................................................. 64 Appendix H ....................................................................................................................................................................... 68 A. Stericycle Standard Mail-Back Package ............................................................................................................ 68 B. Covanta Standard Mail-Back Package ............................................................................................................... 69 C. PureWay Inhaler Mail-Back Package Specifications ...................................................................................... 70 D. Stericycle Inhaler Mail-Back Package .................................................................................................................. 71 Appendix I .......................................................................................................................................................................... 72 MED-Project Request for Approval of Standard Mail-Back Package Disposal Process .............................. 72 Appendix J ......................................................................................................................................................................... 76 MED-Project Request for Approval of Inhaler Mail-Back Package Disposal Process ................................... 76 Appendix K ....................................................................................................................................................................... 80 5 Stericycle, Inc., Indianapolis Facility Penalty Record .............................................................................................. 80 Veolia – Port Arthur Penalty Record ........................................................................................................................... 83 Heritage Thermal Services – Ohio Penalty Record ................................................................................................ 87 Clean Harbors Aragonite Enforcement Summary Fact Sheet .............................................................................. 91 Curtis Bay Energy LP Penalty Record ......................................................................................................................... 94 Daniels Sharpsmart, Inc. Fresno, California Transfer Facility Penalty Record ................................................ 95 Appendix L ....................................................................................................................................................................... 103 Education and Outreach Call Center Script .............................................................................................................103 Appendix M...................................................................................................................................................................... 106 MED-Project Website .................................................................................................................................................... 106 Appendix N ....................................................................................................................................................................... 115 Brochure ............................................................................................................................................................................. 115 Appendix O ....................................................................................................................................................................... 117 Digital and Local Social Networks ............................................................................................................................... 117 6 Introduction MED-Project LLC (“MED-Project”), on behalf of the participating companies identified in Appendix A, submits this Product Stewardship Plan (“Plan”) for Unwanted Medicine to the Alameda County Department of Environmental Health (“Department”) in compliance with the Alameda County Safe Drug Disposal Ordinance, Title 6 of the Alameda County Health and Safety Code Sections 6.53.010 through 6.53.120, as amended February 2, 2016 (“Ordinance”) and the Alameda County Safe Drug Disposal Regulations, as amended October 16, 2013 (“Regulations”). The Ordinance requires pharmaceutical Producers1 to develop a Product Stewardship Program to finance and manage the collection, transportation, and disposal of Unwanted Medicine from Alameda County households. Contact Information The primary contact person for MED-Project is: Dr. Victoria Travis, PharmD, MS, MBA National Program Director MED-Project LLC 1800 M Street NW, Suite 400 S Washington, DC 20036 Phone: 1 (844) 677-6532 Fax: 1 (510) 686-8837 alamedacounty@med-project.org Plan Definitions Board of Pharmacy is the California State Board of Pharmacy. Call Center is the MED-Project call center for Residents, which can be reached by callers at the toll-free number of 1-844-MED-PROJECT or 1-844-633-7765. Carrier is the common carrier used to transport Unwanted Medicine from Kiosk Drop-Off Sites and/or Take- Back Events. County means Alameda County, California. DEA is the U.S. Drug Enforcement Administration. DEA Rule is the DEA Final Rule, “Disposal of Controlled Substances,” 79 Fed. Reg. 53,520 et seq., adopted on September 9, 2014. DOT is the U.S. Department of Transportation. FDA is the U.S. Food and Drug Administration. Help Desk is the MED-Project call center and email-in database for Kiosk Drop-Off Sites that can be reached by callers at a toll-free number and/or by email at alamedacounty@med-project.org. Host-Assisted Collection Kiosk Drop-Off Site is a location that is accessible to the public, hosting a MED- Project kiosk for the collection of Unwanted Medicine, where the Host-Assisted Collection Kiosk Drop-Off Site Host employees will remove, seal, and package boxes and inner liners. 1 All capitalized terms used but not otherwise defined herein shall have their respective meanings set forth in the Ordinance and Regulations. 7 Host-Assisted Collection Kiosk Drop-Off Site Host is the designated contact person or persons at the Host- Assisted Collection Kiosk Drop-Off Site. Inhaler Mail-Back Services is the provision of pre-paid, pre-addressed packages for the collection and disposal of inhalers (“Inhaler Mail-Back Packages”) by Vendor. Kiosk Drop-Off Site is a location that is accessible to the public, hosting a MED-Project kiosk for the collection of Unwanted Medicine, including Host-Assisted Collection Kiosk Drop-Off Sites and Technician- Assisted Collection Kiosk Drop-Off Sites. Kiosk Drop-Off Site Host is the designated contact person or persons at the Kiosk Drop-Off Site, including Host-Assisted Collection Kiosk Drop-Off Site Hosts and Technician-Assisted Collection Kiosk Drop-Off Site Hosts. Law Enforcement Agency or LEA is a federal, state, tribal, or local law enforcement office or agency. Mail-Back Services is the provision of pre-paid, pre-addressed containers, envelopes, or packages (“Mail- Back Packages”) to disabled and home-bound Residents or to persons providing services to such Residents for the collection and disposal of Unwanted Medicine by Vendor. Maintenance Technicians are service personnel who are trained to provide services related to kiosks that are part of the Program. This includes, but is not limited to, responding to damaged kiosks. MED-Project Website is the Internet website located at www.med-project.org or www.medproject.org. Plan or Product Stewardship Plan is the product stewardship plan presented in this submittal by MED- Project. Program or Product Stewardship Program is the product stewardship program set forth in this Product Stewardship Plan. Residents means human beings residing in the County. “Residents” does not include nonresidential generators of pharmaceutical waste, such as businesses, hospitals, clinics, doctor’s offices, veterinary clinics, pharmacies, or airport security and law enforcement drug seizures. Service Technicians are personnel trained to service Program kiosks and/or Take-Back Events. Standard Mail-Back Services is the provision of pre-paid, pre-addressed envelopes for the collection and disposal of Unwanted Medicine (“Standard Mail-Back Packages”) by Vendor. Specified Languages are English, Spanish, Chinese, Vietnamese, and Tagalog (Filipino). Take-Back Event is a one-day event at a location accessible to the public, conducted by MED-Project, with oversight by law enforcement, for the collection of Unwanted Medicine from Residents. Technician-Assisted Collection Kiosk Drop-Off Site is a location that is accessible to the public, hosting a MED-Project kiosk for the collection of Unwanted Medicine, where Service Technicians will assist in removing, sealing, and packaging boxes and inner liners. Technician-Assisted Collection Kiosk Drop-Off Site Host is the designated contact person or persons at the Technician-Assisted Collection Kiosk Drop-Off Site. Unwanted Medicine is defined in Section IV of this Plan. Vendor is any vendor retained by MED-Project to carry out its obligations under the Program. 8 Unwanted Medicine For the purposes of the Plan, “Unwanted Medicine” includes all materials identified as “Covered Drugs” under Ordinance § 6.53.030(3) that qualify as “Unwanted Products” under Ordinance § 6.53.030(21). According to the Ordinance, Covered Drugs means “a Drug sold, offered for sale, or dispensed in Alameda County in any form including prescription and nonprescription drugs, drugs in medical devices and combination products, brand name and generic drugs, and drugs for veterinary use.” Unwanted Medicine does not include the following: i. Expired and/or undispensed samples direct from physicians’ offices; ii. Unused or expired drugs from hospitals and institutions; iii. Bulk animal pharmaceuticals from farms (business use); iv. Vitamins or supplements; v. Herbal-based remedies and homeopathic drugs, products, or remedies; vi. Compressed cylinders and mercury containing thermometers; vii. Cosmetics, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or other personal care products that are regulated as both cosmetics and nonprescription drugs under the federal Food, Drug, and Cosmetic Act (Title 21 U.S.C. Chapter 9); viii. Hard surface and toilet disinfectant cleaners; ix. Drugs administered in a healthcare setting; x. Drugs for which Producers provide a pharmaceutical product stewardship or take-back program as part of a FDA managed risk evaluation and mitigation strategy (Title 21 U.S.C. Sec. 355-1); xi. Drugs that are biological products, as defined by 21 C.F.R. 600.3(h) as it existed on February 2, 2016, if the Producer already provides a pharmaceutical product stewardship or take-back program; xii. Medical devices or their component parts or accessories; xiii. Used, empty containers, vials, and pouches; xiv. Sharps (e.g., needles, auto-injectors); and xv. Schedule I or other illicit drugs. See Section XII.A for collection limitations imposed by the DEA Rule. Collection of Unwanted Medicine The Plan provides services to collect Unwanted Medicine, including controlled substances. The Program will accept Unwanted Medicine regardless of who produced it, unless excused from this requirement by the Department. The collection methods and any applicable legal requirements are described below. A. Unwanted Medicine Collection Program 1. Outreach MED-Project continues to periodically perform outreach to potential collection sites through calls, emails, and/or site visits with the goal of establishing Kiosk Drop-Off Sites distributed throughout the County. LEAs and Pharmacies that currently host kiosks in the County may transition into the Program upon entering into an agreement with MED-Project. 9 2. Implementation MED-Project continues to implement the Program through executed agreements with Kiosk Drop-Off Site Hosts. Take-Back Events will also be conducted in coordination with scheduled Alameda County Department of Environmental Health Household Hazardous Waste (“HHW”)2 events throughout the County. Collection of Unwanted Medicine begins at Kiosk Drop-Off Sites once agreements have been executed with each location, kiosks have been installed, sites have been trained, and, in the case of pharmacies, all requirements of the DEA and Board of Pharmacy have been met. 3. Convenience Mail-Back Services will be available upon request by disabled and home-bound Residents or persons providing services to such Residents via the Call Center and MED-Project Website, thereby offering more opportunities to dispose of Unwanted Medicine. Mail-Back Services will also be available to Residents in underserved areas of the County until MED-Project has met its long-term kiosk installation goals established in Section VI. 4. Services MED-Project will routinely assess performance, gauge feedback, and revise its approach to services and convenience as appropriate. As implementation proceeds, MED-Project shall continue to approach organizations that may be available as future Kiosk Drop-Off Sites on a periodic basis, such as those listed in Appendix B. The Program will be implemented in a flexible manner, offering coverage to Residents through a combination of Kiosk Drop-Off Sites, Mail-Back Services, and Take-Back Events. Over the course of implementation, additional Kiosk Drop-Off Sites will be established to the extent that (1) additional eligible LEAs and/or DEA-registered collector pharmacies agree to participate, and (2) contracts can be executed with such entities. For every engagement with LEAs and pharmacies, including the establishment of Kiosk Drop-Off Sites and/or the conducting of Take-Back Events, contracts outlining the responsibilities of all involved parties will be drafted, reviewed by appropriate entities, and signed by all parties before MED- Project installs kiosks and/or schedules Take-Back Events. For more information regarding Take-Back Event scheduling, coverage, and frequency, see Section V.C. Mail-Back Services will be available to disabled and home-bound Residents or to persons providing services to such Residents and/or Residents in underserved areas of the County upon request and will be reviewed routinely for availability and effectiveness. See Section V.E for more information about the availability of Mail-Back Services. B. Kiosk Drop-Off Sites Kiosk Drop-Off Sites will continue to be strategically placed across the County in order to best serve Residents. All Kiosk Drop-Off Site Hosts shall provide Residents with access to Program kiosks during regular business hours. 2 http://stopwaste.org/recycling/residents/household-hazardous-waste/one-day-event 10 1. Kiosk Drop-Off Site Locations Kiosk Drop-Off Sites that are currently interested in and participating in the Program are identified in Appendix C. MED-Project will continue outreach to potential Kiosk Drop-Off Site Hosts that are not interested in or participating in the Program, such as sites listed in Appendix D. As required under Ordinance § 6.53.070(E), the Plan will include as a Kiosk Drop-Off Site any eligible site willing to serve voluntarily as a Kiosk Drop-Off Site for Unwanted Medicine and able to meet all applicable laws, regulations, and other legal requirements. Locations currently serving as a drop-off site may participate in the MED-Project Program by signing agreements with MED-Project and modifying their DEA registrations, if required. MED-Project will work with the Kiosk Drop-Off Site Host to transition to the Program and Vendor. 2. Drop-Off Site Kiosk Placement and Maintenance Program Kiosk installation shall be the responsibility of MED-Project at LEAs and pharmacy Kiosk Drop-Off Sites when the Kiosk Drop-Off Site Host has identified a compliant placement location. All kiosks in the Program must be securely placed and maintained inside a collector’s registered location or LEA’s physical location in accordance with DEA Rule §§ 1317.75(d)(1) and 1317.35(a). At pharmacies, kiosks will be placed in the immediate proximity of a designated area where controlled substances are stored and at which an employee is present (i.e., can be seen from the counter), pursuant to DEA Rule § 1317.75(d)(2). Kiosk placement will also comply with any applicable Board of Pharmacy requirements. Costs associated with installation and maintenance will be paid by MED-Project per the contracts with the Kiosk Drop-Off Site Hosts. The maintenance program will address items such as: • Periodic inspection of kiosks to monitor general wear and tear; • Service Technician access to the kiosks at Technician-Assisted Collection Kiosk Drop-Off Sites during the regularly scheduled pick-ups and notification of a Maintenance Technician if necessary; and • Reporting by the Kiosk Drop-Off Site Host of damage to a kiosk or requested maintenance service. All Kiosk Drop-Off Site Hosts are able to notify MED-Project of the need for kiosk service or maintenance via the Help Desk. 3. Kiosk Specifications A kiosk will be offered to eligible host locations. Pursuant to DEA Rule § 1317.75, MED-Project kiosks at pharmacies will: • Be securely fastened to a permanent structure; • Be securely locked, substantially constructed containers with a permanent outer container and removable inner liner; • Include a small opening in the outer container that allows contents to be added to the inner liner, but does not allow removal of the inner liner’s contents; • Prominently display a sign indicating that only Schedule II-V controlled and non-controlled substances are acceptable to be placed in the kiosk; and • Have the small opening in the outer container locked or made inaccessible to the public when a Kiosk Drop-Off Site employee is not present. The design of the pharmacy kiosk and signage (Appendix E) satisfies these requirements through the use of heavy gauge steel; multiple locking mechanisms, including a locking mechanism on the drop-slot; a 11 tamper-proof slot; and commercial hinges. The design increases the likelihood of consumer participation by providing easy access to wheelchair users. The locking mechanism on the drop-slot prevents kiosk overflow once the container has reached its maximum level and is locked by the Kiosk Drop-Off Site employee. MED-Project pharmacy kiosks come with appropriate regulatory signage and instructions, including an instruction to remove personal information from any Unwanted Medicine and packaging before depositing them and language required under the DEA Rule3 and by the Board of Pharmacy. Kiosk signage provides information about what is and is not accepted in the kiosk. Additionally, under DEA Rule § 1317.60(a), MED-Project kiosk inner liners will: • Be waterproof, tamper-evident, and tear-resistant; • Be removable and sealable immediately upon removal without emptying or touching kiosk contents; • When sealed, make the contents of the inner liner not viewable from the outside; • Clearly indicate the size of the inner liner; and • Bear a permanent, unique identifier for tracking purposes. MED-Project kiosks and inner liners will also comply with Board of Pharmacy requirements. While the DEA Rule does not require LEA kiosks to meet these same requirements, MED-Project will offer these kiosks and inner liners to LEAs. See Disposal of Controlled Substances, 79 Fed. Reg. 53,520, 53,531 (Sept. 9, 2014). 4. Kiosk Collection Under DEA Rule § 1317.05(c)(2)(iv), pharmacy Kiosk Drop-Off Site Hosts must dispose of sealed inner liners and their contents either on-site, through common or contract carrier delivery to, or pick-up by a reverse distributor or distributor, or with DEA assistance. DEA Rule § 1317.75(c) prohibits the counting, sorting, inventorying, or individual handling of any substances deposited into a pharmacy kiosk. Additionally, DEA Rule § 1317.60 limits inner liner access to employees of the collector and requires two employees to immediately seal the inner liner upon its removal from the pharmacy kiosk’s permanent outer container. See DEA Rule § 1317.60(b), (c). DEA Rule § 1317.75(g) provides that pharmacy kiosk inner liner installation or removal shall be performed “by or under the supervision of at least two employees of the authorized collector.” The pharmacy kiosk sealed inner liner must not be opened, x-rayed, analyzed, or otherwise penetrated. See DEA Rule § 1317.60(c). At LEA Kiosk Drop-Off Sites, Vendor and/or LEA will maintain any records of removal, storage, or destruction of the collected Unwanted Medicine in a manner consistent with the LEAs’ recordkeeping requirements for illicit controlled substances evidence pursuant to DEA Rule § 1317.35. LEAs will record the unique identifier and size of the sealed inner liner transferred to Vendor. See DEA Rule § 1317.35. Additionally, any Unwanted Medicine will be stored in a manner to prevent the diversion of controlled substances and consistent with the LEA’s standard procedures for storing illicit controlled substances. Collected Unwanted Medicine will be transferred to the disposal facility in a manner to prevent the diversion of Unwanted Medicine and consistent with the LEA’s standard procedures for transferring illicit controlled substances. See DEA Rule § 1317.35. MED-Project’s Kiosk Drop-Off Site collection system complies with these DEA requirements for pharmacy and LEA Kiosk Drop-Off Sites. Vendor, pharmacies, and LEAs participating in the Program will keep all records required under the DEA Rule, including those required under DEA Rule §§ 1304 and 1317.35. Pharmacies participating in the Program will also keep all records required under Board of Pharmacy 3 Specifically, as required under DEA Rule § 1317.75(e)(4), all kiosks will prominently display a sign stating that: “Only Schedule II-V controlled and non-controlled substances that are lawfully possessed by the ultimate user are acceptable to be placed in the kiosk. Schedule I controlled substances, illicit or dangerous substances, and any controlled substances not lawfully possessed by the ultimate user may not be placed in the kiosk.” 12 requirements. Pharmacy Kiosk Drop-Off Sites and Vendor will be instructed never to count, sort, inventory, or individually handle kiosk contents. MED-Project’s Kiosk Drop-Off Site collection system will also comply with all applicable Board of Pharmacy requirements. A Kiosk Drop-Off Site may elect to participate in the program via either the technician-assisted collection method or host-assisted collection method. If a Kiosk Drop-Off Site elects to participate via the technician- assisted collection method, a Service Technician will regularly come to the Technician-Assisted Collection Kiosk Drop-Off Site to help prepare the inner liner for shipment and disposal. If a Kiosk Drop-Off Site elects to participate via the host-assisted collection method, the Host-Assisted Collection Kiosk Drop-Off Site employees will prepare the inner liner for shipment. a. Technician-Assisted Collection For Kiosk Drop-Off Sites that opt to participate via the technician-assisted collection method, pick-up of Unwanted Medicine collected at the sites will be scheduled year-round, based on their regular business hours and volume collected. After arriving at a Technician-Assisted Collection Kiosk Drop-Off Site, the Service Technician will check the kiosk for any damage. The inner liner and box will be securely removed from the kiosk by a Service Technician and Technician- Assisted Collection Kiosk Drop-Off Site employees following procedures meeting all DEA requirements. Specifically, two Technician-Assisted Collection Kiosk Drop-Off Site employees will hold the two keys to unlock the kiosk. Once the kiosk is unlocked, the inner liner will be removed from the kiosk and immediately sealed. The inner liner provided in the kiosk will be opaque to prevent visual recognition of the contents. The sealed inner liner will not be opened, x-rayed, analyzed, or otherwise penetrated. Under the supervision of two Technician-Assisted Collection Kiosk Drop-Off Site employees, the Service Technician will prepare the liner for packaging and transport. The unique identifier of the inner liner will be matched to the tracking number on the shipping label. The Service Technician will schedule a pickup from the Carrier to be completed within two business days and leave the packaged, sealed inner liner with the Technician-Assisted Collection Kiosk Drop-Off Site Host for storage in compliance with all applicable laws, regulations, and other legal requirements until Carrier pickup. Vendor will prepare the materials for shipment and perform applicable pre-transportation functions to comply with DOT Hazardous Materials Regulations. Any collection of controlled substances by LEA will be consistent with the LEA’s standard procedures for transferring illicit controlled substances. See DEA Rule § 1317.35. b. Host-Assisted Collection Host-assisted collection will enable a site to directly control the timing for servicing the kiosk by allowing the site employees to prepare the liner for packaging and transport at a time of their choosing. This method will allow sites to avoid disruptions to operations that may result from Vendor-scheduled visits or storage limitations. MED-Project will provide Host-Assisted Collection Kiosk Drop-Off Site Hosts with information related to servicing kiosks and applicable laws, regulations, and other legal requirements when installing the kiosks and upon request through the Help Desk. Unwanted Medicine will be securely removed from the kiosk by Host-Assisted Collection Kiosk Drop-Off Site employees following procedures meeting all DEA requirements. Specifically, two Host-Assisted Collection Kiosk Drop-Off Site employees will hold the two keys to unlock the kiosk. Once the kiosk is unlocked, the inner liner will be removed from the kiosk and immediately sealed. The inner liner provided in the kiosk will be opaque to prevent visual recognition of the contents. The sealed inner liner will not be opened, x-rayed, analyzed, or otherwise penetrated. Following instructions provided by Vendor, the two Host-Assisted Collection Kiosk Drop-Off Site employees will seal the inner liner for packaging and transport. The unique identifier of the inner liner will 13 be matched to the tracking number on the shipping label. The two Host-Assisted Collection Kiosk Drop-Off Site employees will either schedule a pickup from the Carrier to be completed within two business days or offer the packaging containing the sealed inner liner for pickup a routine Carrier service to the Host- Assisted Collection Kiosk Drop-Off Site. If the package containing the sealed inner liner is prepared prior to pick-up, the Host-Assisted Collection Kiosk Drop-Off Site Host will store the inner liner in compliance with all applicable laws, regulations, and other legal requirements until Carrier pickup. Following instructions provided by Vendor, the two Host-Assisted Collection Kiosk Drop-Off Site employees will prepare the materials for shipment and perform applicable pre-transportation functions to comply with DOT Hazardous Materials Regulations. Following instructions provided by Vendor, the two Host-Assisted Collection Kiosk Drop-Off Site employees will replace the removed inner liner and box with a replenishment inner liner and box, provided by Vendor. Each inner liner and box provided by Vendor will be pre-paid and pre-addressed for transport and disposal. Any collection of controlled substances by LEA will be consistent with the LEA’s standard procedures for transferring illicit controlled substances. See DEA Rule § 1317.35. 5. Frequency of Pick-Up Initially, all Technician-Assisted Collection Kiosk Drop-Off Sites will be scheduled for a monthly pick-up from the kiosk. The Vendor will communicate with MED-Project in the event that the frequency of pick-up needs to be changed based on the volumes collected over time. As needed, MED-Project will communicate with the Technician-Assisted Collection Kiosk Drop-Off Site Host in the event the frequency of pick-up needs to be changed. Vendor will monitor the volumes per service to ensure that all sites are receiving the appropriate service frequency. Vendor will manage pick-up services as frequently as necessary to prevent overflow of the kiosk without providing unnecessary interruption to the participating Technician-Assisted Collection Kiosk Drop-Off Site. Host-Assisted Collection Kiosk Drop-Off Sites will be instructed to service the kiosk and request a pick-up by Carrier, as needed. Vendor will monitor the weight of Unwanted Medicine generated at each participating Kiosk Drop-Off Site. 6. Procedures if a Kiosk is Full Prior to Scheduled Pick-Up The Technician-Assisted Collection Kiosk Drop-Off Site Host shall be instructed to lock the drop-slot of the kiosk and notify MED-Project of the need for service if prior to the scheduled date. Vendor shall provide a network of trained Service Technicians. Vendor will communicate service requests to field managers responsible for Service Technicians. Vendor will direct service to the trained Service Technician who is in closest proximity to the Technician-Assisted Collection Kiosk Drop-Off Site requesting the service. This process provides for a timely response to Technician-Assisted Collection Kiosk Drop-Off Sites requiring service prior to the scheduled date. Service timelines will be assessed based on the specific characteristics of the Technician-Assisted Collection Kiosk Drop-Off Site’s need. If necessary, Vendor will be able to respond within hours of the request. If the request does not require an urgent response, Vendor will respond within two business days of the request. In the interim, pharmacy Technician-Assisted Collection Kiosk Drop-Off Site Hosts shall be instructed to secure the kiosk and its contents in accordance with DEA requirements. Host-Assisted Collection Kiosk Drop-Off Sites will be instructed to service the kiosk and request a pick-up by Carrier, as needed. 14 7. Unplanned Event Preparedness Vendor maintains a network of emergency responders that can be called on in the case of an emergency or spill incident. Vendor ensures compliance of all service providers through a business confidential qualification process. This process reviews the compliance history, management structure, financial stability, and other key indicators of a reliable emergency response service provider. Emergency responders will bring all necessary equipment in order to manage the specific needs of the Kiosk Drop-Off Site requiring emergency response. Kiosk Drop-Off Site Hosts will be directed to call 911 in situations posing an immediate threat to health or the environment. A major event, such as a flood, earthquake or fire, may require response by a service team. This event can jeopardize the security characteristics of the kiosk as well as the structural integrity of the participating location. The team will assess the safety of the area along with the locations to be serviced. Once it is determined the area is safe for access, the team will work to secure the kiosk and remove its contents. Along with major event preparedness, Vendor provides timely responses to events that may cause an inconvenience to the Kiosk Drop-Off Site Host. An example of this kind of event would be if the kiosk is giving off an odor prior to the scheduled service date. The Kiosk Drop-Off Site Host will contact MED- Project via the Help Desk. Vendor is able to respond within two to three hours in most cases when notified of a need for emergency response. If the request is not an emergency that requires an immediate response, Vendor will typically respond to a service location within two to three business days of the event. An event may occur, such as a site requiring an emergency response or an LEA that is unwilling or unable to securely store inner liners prepared for shipment, that necessitates a direct transport of a sealed inner liner from a Kiosk Drop-Off Site to a disposal facility listed in Section X. In such cases, a Service Technician will seal the kiosk inner liner for packaging and transport according to the process outlined in Section V.B.4.a. The packaged inner liner will then be transported to one of the disposal facilities listed in Section X. In addition, any items that a Resident deposits into the kiosk will not be retrieved. C. Take-Back Events MED-Project will conduct Take-Back Events in coordination with HHW events throughout the County. MED- Project may also conduct Take-Back Events upon request by LEAs. LEA employees shall oversee all Take- Back Events. MED-Project will confirm and/or finalize the locations and dates to conduct Take-Back Events once contracts with overseeing LEAs have been executed. Due to the changing schedule of Take-Back Events, the list of dates and locations will be maintained on the MED-Project Website as events are scheduled and confirmed. 1. Method The conducting of Take-Back Events by MED-Project is contingent upon participation and oversight by LEAs. MED-Project will work with participating LEAs to ensure Take-Back Events are compliant and successful. Events will be promoted and communicated to the public through local communication channels as outlined in Appendix F. MED-Project Take-Back Events will meet all applicable laws, regulations, and other legal requirements. MED-Project will contract with LEAs to oversee Take-Back Events. MED-Project will work with LEAs to accommodate any reasonable requirements. 15 2. Procedures MED-Project will partner with LEAs to ensure that at least one law enforcement officer oversees collection at all Take-Back Events pursuant to DEA Rule § 1317.65(a), (b). The law enforcement officers will maintain control and custody of all Unwanted Medicine collected at Take-Back Events from collection until secure transfer, storage, or destruction of the Unwanted Medicine, as required by DEA Rule § 1317.65(b). Only ultimate users and persons authorized to dispose of an ultimate user decedent’s property in lawful possession of controlled substances in Schedules II-V may transfer these substances to the LEA during the event. No other person will handle controlled substances at Take-Back Events under DEA Rule § 1317.65(e); however, Vendor may assist LEAs in the collection of Unwanted Medicine at Take-Back Events. See Disposal of Controlled Substances, 79 Fed. Reg. 53,520, 53,539 (Sept. 9, 2014). Take-Back Events will typically be staffed by at least two Vendor employees. Vendor will work in coordination with MED-Project, the County, and LEAs to monitor and ensure collection of all material at Take-Back Events is compliant with all applicable laws, regulations, and other legal requirements and meets the published expectations of the planned event. Vendor will work in conjunction with law enforcement to ensure all material is placed in a compliant collection receptacle and securely shipped to meet all applicable laws, regulations, and other legal requirements. Any material that is not Unwanted Medicine or does not meet legal requirements will be rejected. Vendor and the LEA will maintain all records of collection, storage, or destruction of the collected Unwanted Medicine in a manner consistent with the LEA’s recordkeeping requirements for illicit controlled substances evidence pursuant to DEA Rule § 1317.35. Any collected Unwanted Medicine will be stored to prevent the diversion of controlled substances and consistent with the LEA’s standard procedures for storing illicit controlled substances. Any storage of Unwanted Medicine by Vendor will also comply with the applicable security requirements of DEA Rule §§ 1301 and 1317, including the requirement that Unwanted Medicine is securely stored in a manner consistent with the security requirements for Schedule II controlled substances. Following the completion of each event, containers will be weighed, securely packaged, labeled, transported from the event site to the LEA site, and shipped in compliance with all applicable laws, regulations, and other legal requirements. Law enforcement officers will maintain control and custody of all Unwanted Medicine collected at Take-Back Events while it is transported to the point of secure transfer, storage or destruction. Containers and inner liners will be tracked via unique identifiers to a facility identified in Section X, where they shall be incinerated. Vendor will ship the containers (and inner liners) in accordance with the requirements outlined in Section XII.B. D. Disposal of Unwanted Medicine from Kiosk Drop-Off Sites and Take-Back Events Vendor and Carrier shall manage the Unwanted Medicine from Kiosk Drop-Off Sites and Take-Back Events in compliance with all applicable laws, regulations, and other legal requirements. Carrier and/or Vendor shall deliver Unwanted Medicine collected from Kiosk Drop-Off Sites and/or Take-Back Events to the respective facilities identified in Section X. All inner liners will be destroyed in accordance with all applicable laws, regulations, and other legal requirements at the disposal facilities identified in Section X. MED-Project’s request for approval to dispose of Host-Assisted Collection Kiosk Drop-Off Site inner liners at a municipal waste incinerator is included in Appendix G. 16 E. Mail-Back Services for Unwanted Medicine MED-Project will provide two types of Mail-Back Services: • Standard Mail-Back Services for disabled and home-bound Residents or persons providing services to such Residents and to supplement kiosks until the convenience standard is met, as described in Section V.E.1; • Inhaler Mail-Back Services for the collection of inhalers for disabled and home-bound Residents or persons providing services to such Residents as described in Section V.E.2. Mail-Back Packages will be pre-paid and pre-addressed, and Mail-Back Services shall comply with all applicable laws, regulations, and other legal requirements. 1. Standard Mail-Back Services for Unwanted Medicine MED-Project will provide Standard Mail-Back Services at no cost to disabled and home-bound Residents or to persons providing services to such Residents. Standard Mail-Back Packages will also be available to Residents in underserved areas of the County until MED-Project has met its long-term kiosk installation goals. The pre-paid shipping label will direct the Standard Mail-Back Package to the facility identified in Section X. Standard Mail-Back Packages for Unwanted Medicine shall comply with all applicable laws, regulations, and other legal requirements. Pursuant to DEA Rule § 1317.70(c), the Standard Mail-Back Packages will be: • Nondescript and without any markings or information potentially indicating that they contain Unwanted Medicine, including controlled substances; • Water and spill-proof, tamper-evident, tear-resistant, and sealable; • Pre-addressed with and delivered to Vendor’s registered address; • Pre-paid; • Provided with a unique identifier enabling tracking; and • Provided with instructions indicating the process for mailing back the packages, accepted substances, a notice about mailing restrictions, and a notice that only packages provided by Vendor will be accepted for destruction. Ultimate users and persons lawfully entitled to dispose of an ultimate user decedent’s property will not be required to provide any personally identifiable information when using Standard Mail-Back Services to dispose of Unwanted Medicine. See DEA Rule § 1317.70(d). As required under DEA Rule § 1317.70(e), Vendor will only accept Standard Mail-Back Packages it made available (or packages lawfully forwarded under DEA requirements). Within three business days of receipt, Vendor will notify the DEA if it receives Standard Mail-Back Packages likely containing controlled substances that Vendor did not make available or did not agree to receive pursuant to DEA requirements. In accordance with DEA Rule § 1317.70(f), when Standard Mail-Back Packages are received, only employees of Vendor will handle the Standard Mail-Back Packages. Standard Mail-Back Packages will not be opened, x-rayed, analyzed, or otherwise penetrated upon receipt by Vendor. See DEA Rule § 1317.70(f). Vendor will keep all records required under the DEA Rule, including those identified in DEA Rule § 1304.22(f). See Appendix H for Standard Mail-Back Package image and package specifications. 17 2. Inhaler Mail-Back Services for Inhalers For inhalers, MED-Project will offer disabled and home-bound Residents or persons providing services to such Residents Inhaler Mail-Back Services via the Call Center and MED-Project Website. The pre-paid shipping label will direct the Inhaler Mail-Back Packages to an approved facility identified in Section X. An instruction sheet will be included with the Inhaler Mail-Back Package that describes how to properly dispose of inhalers, explains what materials may be placed in the Inhaler Mail-Back Package, and how to return the Inhaler Mail-Back Package. See Appendix H for an Inhaler Mail-Back Package image and package specifications. 3. Mail-Back Package Availability Disabled and home-bound Residents or persons providing services to such Residents may request Standard Mail-Back Packages and/or Inhaler Mail-Back Packages by calling the Call Center or through a link on the MED-Project Website. Upon request, such Residents will be provided Mail-Back Packages. Standard Mail-Back Packages will also be available to Residents in underserved areas of the County until MED-Project has met its long-term kiosk installation goals. Once the long-term kiosk installation goals have been met, Standard Mail-Back Services will only be available to disabled and home-bound Residents or to persons providing services to such Residents. Each Mail-Back Package will contain an insert with instructions for use and information about other options for disposing of Unwanted Medicine in the Specified Languages. See Appendix H for Mail-Back Package images. 4. Mail-Back Package Collection and Disposal Requests to receive Mail-Back Packages will be taken through the Call Center and the MED-Project Website. Residents will be directed to follow the instructions provided in the Mail-Back Package and to place their Unwanted Medicine in the pre-addressed, pre-paid package. The Mail-Back Package shall be sent to an approved disposal facility in compliance with all applicable laws, regulations and other legal requirements. Each Mail-Back Package will have a unique identifier for tracking. For Standard Mail-Back Packages, upon arriving at the disposal facility, the Mail-Back Packages will be scanned for receipt verification and incinerated at the disposal facilities listed in Section X. MED-Project’s request for approval to dispose of Standard Mail-Back Packages at a municipal waste incinerator is included in Appendix I. Any storage of filled Standard Mail-Back Packages by Vendor will comply with the applicable security requirements of DEA Rule § 1317, including the requirement that Unwanted Medicine is securely stored in a manner consistent with the security requirements for Schedule II controlled substances. All Unwanted Medicine in Standard Mail-Back Packages will be destroyed promptly. This Plan proposes to dispose of Inhaler Mail-Back Packages at a municipal waste combustor and/or a medical waste incinerator. See the facilities identified in Section X. MED-Project’s request for approval to use a municipal waste combustor to dispose of inhalers collected through Inhaler Mail-Back Packages is included in Appendix J. 18 Plan and Collection Goals The short- and long-term goals of the Plan are described generally as follows. Additional detail on implementation is provided in Section V.A.2. Goal Area Short-Term Long-Term Collection Within 90 days of Plan approval, implement Mail-Back Services for disabled and home-bound Residents, persons providing services to such Residents, and Residents in underserved areas of the County. Continue to increase retail chain pharmacy participation through outreach, with a goal of achieving up to a total of 100 Kiosk Drop-Off Sites. Reduce collection via Take-Back Events and Mail-Back Services by establishing additional Kiosk Drop-Off Sites throughout the County. Education & Public Outreach Within 90 days of Plan approval, include Mail-Back Services for disabled and home-bound Residents, persons providing services to such Residents, and Residents in underserved areas of the County on the Call Center and MED- Project Website. Within 90 days of Plan approval, implement the Specified Languages on the Call Center and MED-Project Website. Within 90 days of Plan approval, release a Public Service Announcement (“PSA”) animation directed at Residents on social media websites, digital media, print, and broadcast (television). Within 90 days of approval release audio PSA via radio. See Section XI for more information about education and outreach programming. On an ongoing basis, MED-Project may revise and add communications materials based on changes to the Plan. Collector Outreach Periodic outreach to potential eligible Kiosk Drop-Off Sites via site visits, calls, and emails. Ongoing communication with pharmacies and LEAs. Periodic evaluation and monitoring of participating Kiosk Drop-Off Sites. MED-Project continues to implement Kiosk Drop-Off Sites in eligible locations that best serve the demographics and distribution of Residents. See Section V.B for more information about Kiosk Drop-Off Site collection. In addition, MED-Project will conduct Take-Back Events throughout the year, in coordination with HHW events. MED-Project Mail-Back Packages will be made available to disabled and home-bound Residents, persons providing services to such Residents, and Residents in underserved areas of the County by request through the Call Center and MED-Project Website. 19 Patient Privacy Instructions at each Kiosk Drop-Off Site will inform people who deposit Unwanted Medicine that they should completely cross out, remove, or otherwise make unreadable any and all personally identifiable information on the drug containers and packaging before depositing them in the kiosk. In cases where people follow the instructions, there will be no readable personally identifiable information. In addition to kiosk signage, MED-Project instructions, promotional, and educational materials encourage Residents to protect their information by ensuring that personally identifiable information is unreadable when utilizing Mail-Back Services or depositing Unwanted Medicine into kiosks. Materials to help Residents cross out any personally identifiable information will also be available at Take- Back Events. This will ensure any patient information on drug packaging will be unreadable. Vendor has additional protections available for keeping personally identifiable information safe and secure. Service Technicians are trained in managing items containing sensitive patient information. Privacy training is part of a Service Technician’s prerequisite for field services. As added protection, Mail-Back Packages used for Mail-Back Services will be opaque rather than clear. In addition, inner liners used at Kiosk Drop- Off Sites and Take-Back Events will be opaque rather than clear, in compliance with the DEA Rule. This will prevent anyone, including the Service Technician, from seeing any information on the Unwanted Medicine placed in the kiosks. Any patient information on collected drug packaging will be promptly destroyed with the Unwanted Medicine. Call Center MED-Project will operate a Call Center for Residents in the Specified Languages. Questions from Residents will be managed through the Call Center with the support of an agent. All agents are trained to respond based on the requirements set by MED-Project. The agents will answer general questions, including questions on the following topics: 1. Items that can be disposed of; 2. Disposal options; and 3. Direction to the MED-Project Website for additional information. Because the list of Kiosk Drop-Off Sites and Take-Back Events is subject to change, Residents will be directed to the MED-Project Website or to an agent for detailed information about locations and contact information. Training Operational procedures, including training, are the responsibility of the Kiosk Drop-Off Site Host. MED- Project will support training if agreed to with the Kiosk Drop-Off Site Host. Additionally, MED-Project will manage a help desk to answer questions and monitor comments for participating Kiosk Drop-Off Sites. The help desk will support two general communication functions: 1. Answer questions and monitor comments from participating Kiosk Drop-Off Site Hosts; and 2. Support and direct service requests from participating Kiosk Drop-Off Sites. 20 Vendor will comply with all applicable laws, regulations, and other legal requirements. Vendor’s internal training process will address the following: • Onboarding & on-truck observation of job functions; • DOT Training; • DEA Training; • United States Environmental Protection Agency (“EPA”) Waste Characterization; • Occupational Safety and Health Administration (“OSHA”) Training; • Waste Handling Demo; • Truck Operation; • DEA Handling Demo; • Health Insurance Portability and Accountability Act (“HIPAA”) requirements; • OSHA Bloodborne Pathogens Standard; • Review & Written Test; and • Perform work under supervision to demonstrate proficiency prior to certification to service client accounts. A. Service Technician Training The Service Technicians collecting and packaging the Unwanted Medicine for transport from Technician- Assisted Collection Kiosk Drop-Off Sites will complete comprehensive training. This training includes instruction on: • DOT hazardous materials requirements; • EPA waste characterization requirements; • Resource Conservation and Recovery Act (“RCRA”) hazardous waste requirements; • DEA controlled substances transfer protocols; • OSHA requirements; and • HIPAA requirements. Service Technicians must complete a 24 or 40-hour Hazardous Waste Operations and Emergency Response Standard course. Additionally, Service Technicians must complete annual refresher training. Finally, Service Technicians receive ongoing training through meetings and online refresher courses. All Vendor employees servicing Technician-Assisted Collection Kiosk Drop-Off Sites, Mail-Back Services, and/or Take-Back Events will have a training base similar to that of Service Technicians, with customized training as needed. 21 Vendor, Transporter, and Disposal Facility Information All Vendors, transporters, and disposal facilities utilized by the Program will operate in accordance with all applicable laws, regulations, and other legal requirements.4 Technician-Assisted Collection Kiosk Drop-Off Site and Take-Back Event Collection Services A. Vendor for Technician-Assisted Collection Kiosk Drop-Off Sites and Take-Back Events • Name: Stericycle Specialty Waste Solutions, Inc. (“Stericycle”) will service Technician-Assisted Collection Kiosk Drop-Off Sites. Stericycle may also service Take-Back Events. • Address: 2850 100th Court NE, Blaine, MN 55449 • Phone: (612) 285-9865 • Website: www.stericycleenvironmental.com • US DOT No: 1348411, Status: Issued • DOT ID No: MNS 000 110 924, Status: Issued • Penalty Record (5 years): None B. Carrier for Technician-Assisted Collection Kiosk Drop-Off Sites and Take-Back Events • Name: United Parcel Service, Inc. may transport Unwanted Medicine from Technician-Assisted Collection Kiosk Drop-Off Sites to the Stericycle, Inc., Indianapolis, Indiana Facility or the Stericycle, Inc., Warren, Ohio Facility. United Parcel Service, Inc. may also transport Unwanted Medicine from Take-Back Events to the Stericycle, Inc., Indianapolis, Indiana Facility or the Stericycle, Inc., Warren, Ohio Facility. • Address: 55 Glenlake Parkway NE, Atlanta, GA 30328 • Phone: (800) PICK-UPS • Website: www.UPS.com/ • Type: Common Carrier • U.S. Small Package DOT No: 21800, Status: Issued • U.S. Freight DOT No: 121058, Status: Issued • Penalty Record (5 years): For enforcement history, UPS advises that “all material government investigation and enforcement activity is provided in our SEC filings at investors.ups.com” 4 Two witnesses of the registrant will witness destruction at the disposal facilities. 22 C. Reverse Distributor Facility & Transporters for Technician-Assisted Collection Kiosk Drop- Off Sites and Take-Back Events 1. Reverse Distributor Facility • Name: Stericycle, Inc., Indianapolis, Indiana Facility will receive Unwanted Medicine from United Parcel Service, Inc. • Address: 2670 Executive Drive, Suite A, Indianapolis, IN 46241-9901 • Phone: (317) 275-7530 • Website: www.stericycleenvironmental.com • Type: DEA Registered Collector and Reverse Distributor & Permitted Hazardous Waste (RCRA) Treatment, Storage, and/or Disposal Facility • DEA Registration No: RS0331607, Status: Issued • EPA ID No: INR000110197, Status: Issued • TSDF (RCRA) Permit No: INR000110197, Status: Issued • Solid Waste Processing Facility Permit No: FP 49-57, Status: Issued • Air Quality Permit No: E097-28740-00671, Status: Issued • Penalty Record (5 years): See Appendix K 2. Transporter 1 • Name: Heritage Transport may transport Unwanted Medicine from the Stericycle, Inc., Indianapolis, Indiana Facility to Heritage Thermal Services-Ohio. • Address: 1626 Research Way, Indianapolis, IN 46231 • Phone: (317) 486-2973 • Website: http://www.heritage-enviro.com/ • Type: Hazardous Waste Transporter • EPA ID No: IND 058 484 114, Status: Issued • US DOT No: 314460, Status: Issued • Penalty Record (5 years): None 3. Transporter 2 • Name: Veolia – Port Arthur may be used to transport Unwanted Medicine from the Stericycle, Inc., Indianapolis, Indiana Facility to Veolia – Port Arthur. • Address: 7665 Texas Highway 73, Beaumont, TX 77705 • Phone: (409) 736-2821 • Website: www.veolianorthamerica.com • Type: Hazardous Waste Transporter • EPA ID No: TXD000838896, Status: Issued • State Title V Permit No: O-01509, Status: Issued • Air Permit No: NSR Air, Status: Issued • Water Permit No: TPDES02417, Status: Issued • TSDF (RCRA) Permit No: HW-50212, Status: Issued • Penalty Record (5 years): See Appendix K 23 4. Transporter 3 • Name: Stericycle Specialty Waste Solutions, Inc. may transport Unwanted Medicine from the Stericycle, Inc., Indianapolis, Indiana Facility to Heritage Thermal Services – Ohio, Veolia-Port Arthur, the Stericycle, Inc., Warren, Ohio Facility, and/or Clean Harbors – Aragonite. Stericycle Specialty Waste Solutions, Inc. may also be used to transport Unwanted Medicine from Kiosk Drop- Off Sites and/or Take-Back Events to any of the disposal facilities listed in Section X.D or Section X.H. • Address: 2850 100th Court NE, Blaine, MN 55449 • Phone: (612) 285-9865 • Website: www.stericycleenvironmental.com • Type: Hazardous Waste Transporter • US DOT No: 1348411, Status: Issued • DOT ID No: MNS 000 110 924, Status: Issued • Penalty Record (5 years): None D. Disposal Facilities for Technician-Assisted Collection Kiosk Drop-Off Sites and Take-Back Events 1. Disposal Facility 1 • Name: Heritage Thermal Services – Ohio may incinerate Unwanted Medicine received from the Stericycle, Inc., Indianapolis, Indiana Facility. • Address: 1250 Saint George Street, East Liverpool, OH 43920 • Phone: (800) 545-7655 • Website: http://www.heritage-thermal.com/ • Type: Permitted Hazardous Waste Incinerator • DEA Registration No: RH0387628, Status: Issued • RCRA Permit No: OHD980613541, Status: Issued • EPA ID No: OHD 980 613 541, Status: Issued • Ohio ID No: 02-15-0589, Status: Issued • Penalty Record (5 years): See Appendix K 2. Disposal Facility 2 • Name: Veolia – Port Arthur may incinerate Unwanted Medicine received from the Stericycle, Inc., Indianapolis, Indiana Facility. • Address: 7665 Texas Highway 73, Beaumont, TX 77705 • Phone: (409) 736-2821 • Website: www.veolianorthamerica.com • Type: Permitted Hazardous Waste Incinerator • EPA ID No: TXD000838896, Status: Issued • State Title V Permit No: O-01509, Status: Issued • Air Permit No: NSR Air, Status: Issued • Water Permit No: TPDES02417, Status: Issued • TSDF (RCRA) Permit No: HW-50212, Status: Issued • Penalty Record (5 years): See Appendix K 24 3. Disposal Facility 3 • Name: Stericycle, Inc., Warren, Ohio Facility may incinerate Unwanted Medicine received from the Stericycle, Inc., Indianapolis, Indiana Facility. • Address: 1901 Pine Avenue, S.E., Warren, OH 44483 • Phone: (330) 393-0370 • Website: https://www.stericycle.com/service-locations/ohio/warren • Type: Medical Waste Incinerator • DEA Registration No: RS0498130, Status: Issued • Solid Waste Operating Permit No: CID 41805, Status: Issued • Final Air Pollution Control Title V Permit No: P0115341, Status: Issued • Penalty Record (5 years): None 4. Disposal Facility 4 • Name: Clean Harbors - Aragonite may incinerate Unwanted Medicine received from the Stericycle, Inc., Indianapolis, Indiana Facility. • Address: 3 Miles E 7 Miles N of Knolls, Wendover, UT 84083 • Phone: (435) 884-8900 • Website: www.cleanharbors.com • Type: Permitted Hazardous Waste Incinerator • US EPA ID No: UTD981552177, Status: Issued • TSDF (RCRA) Permit No: UTD981552177, Status: Issued • State Title V Permit No: 4500048002, Status: Issued • Air Permit No: DAQE-168-02, Status: Issued • Penalty Record (5 years): See Appendix K Host-Assisted Collection Kiosk Drop-Off Sites E. Vendors for Host-Assisted Collection Kiosk Drop-Off Sites 1. Vendor 1 • Name: Covanta Environmental Solutions, LLC may provide boxes and inner liners for Host-Assisted Collection Kiosk Drop-Off Sites. • Address: 7326 E. Evans Road Suite B, Scottsdale, AZ 85620 • Phone: (855) 269-1750 • Website: www.covantaes.com • DEA Registration No: RC0518160, Status: Issued • Penalty Record (5 years): None 2. Vendor 2 • Name: Stericycle Specialty Waste Solutions, Inc. may provide boxes and inner liners for Host- Assisted Collection Kiosk Drop-Off Sites. • Address: 2850 100th Court NE Blaine, MN 55449 • Phone: (612) 285-9865 • Website: www.stericycleenvironmental.com • US DOT No: 1348411, Status: Issued • DOT ID No: MNS 000 110 924, Status: Issued • Penalty Record (5 years): None 25 F. Carrier for Host-Assisted Collection Kiosk Drop-Off Sites • Name: United Parcel Service, Inc. may transport Unwanted Medicine from Host-Assisted Collection Kiosk Drop-Off Sites to the Covanta Environmental Solutions, LLC Scottsdale, Arizona Facility or the Covanta Manheim, Pennsylvania Facility. United Parcel Service, Inc. may also transport Unwanted Medicine from Host-Assisted Collection Kiosk Drop-Off Sites to the Stericycle, Inc., Indianapolis, Indiana Facility or the Stericycle, Inc., Warren, Ohio Facility. • Address: 55 Glenlake Parkway NE, Atlanta, GA, 30328 • Phone: 800-PICK-UPS • Website: www.UPS.com/ • Type: Common Carrier • U.S. Small Package DOT No: 21800, Status: Issued • U.S. Freight DOT No: 121058, Status: Issued • Penalty Record (5 years): For enforcement history, UPS advises that “all material government investigation and enforcement activity is provided in our SEC filings at investors.ups.com” G. Reverse Distributor Facility & Transporter for Host-Assisted Collection Kiosk Drop-Off Sites 1. Reverse Distributor Facility 1 • Name: Covanta Environmental Solutions, LLC Scottsdale, Arizona Facility may receive Unwanted Medicine from United Parcel Service, Inc. • Address: 7326 E. Evans Road, Suite B, Scottsdale, AZ 85620 • Phone: (855) 269-1750 • Website: www.covantaes.com • Type: DEA Registered Collector and Reverse Distributor • DEA Registration No: RC0518160, Status: Issued • Special Permit No: DOT-SP 20255, Status: Issued • Penalty Record (5 years): None 2. Reverse Distributor Facility 2 • Name: Covanta Manheim, Pennsylvania Facility may receive Unwanted Medicine from United Parcel Service, Inc. • Address: 190 Shellyland Road, Manheim, PA 17545 • Phone: (717) 653-8882 • Website: www.covantaes.com • Type: DEA Registered Collector and Reverse Distributor • DEA Registration No: RC0322595, Status: Issued • Penalty Record (5 years): None 26 3. Reverse Distributor Facility 3 • Name: Stericycle, Inc., Indianapolis, Indiana Facility may receive Unwanted Medicine from United Parcel Service, Inc. • Address: 2670 Executive Drive, Suite A, Indianapolis, IN 46241-9901 • Phone: (317) 275-7530 • Website: www.stericycleenvironmental.com • Type: DEA Registered Collector and Reverse Distributor & Permitted Hazardous Waste (RCRA) Treatment, Storage, and/or Disposal Facility • DEA Registration No: RS0331607, Status: Issued • EPA ID No: INR000110197, Status: Issued • TSDF (RCRA) Permit No: INR000110197, Status: Issued • Solid Waste Processing Facility Permit No: FP 49-57, Status: Issued • Air Quality Permit No: E097-28740-00671, Status: Issued • Penalty Record (5 years): See Appendix K 4. Transporter 1 • Name: Transchem Environmental, LLC may transport Unwanted Medicine from the Covanta Environmental Solutions, LLC Scottsdale, Arizona Facility to the Covanta Long Beach, California Facility Solid Waste Combustor. • Address: 542 East 27th Street, Tucson, AZ 85713 • Phone: (602) 344-4536 • Website: www.tcenv.com • Type: Contract Carrier • US EPA ID No: AZD982484578, Status: Issued • US DOT No: 1341480, Status: Issued • Penalty Record (5 years): None 5. Transporter 2 • Name: Doncin Transport, Inc. may transport Unwanted Medicine from the Covanta Manheim, Pennsylvania Facility to the Curtis Bay Energy, LP Medical Waste Incinerator. • Address: 3478 Sunnyside Rd., Manheim, PA 17545 • Phone: (602) 344-4536 • Website: http://www.truckdrivingcdljobs.com/in/Pennsylvania/Manheim/DONCIN%20TRANSPORT%20INC.p hp • Type: Contract Carrier • US DOT Number: 001625457, Status: Issued • Penalty Record (5 years): None 6. Transporter 3 • Name: Stericycle Specialty Waste Solutions, Inc. may transport Unwanted Medicine from the Stericycle, Inc., Indianapolis, Indiana Facility to the Stericycle, Inc., Warren, Ohio Facility. • Address: 2850 100th Court NE, Blaine, MN 55449 • Phone: (612) 285-9865 • Website: www.stericycleenvironmental.com • Type: Hazardous Waste Transporter • US DOT No: 1348411, Status: Issued • DOT ID No: MNS 000 110 924, Status: Issued • Penalty Record (5 years): None 27 H. Disposal Facilities for Host-Assisted Collection Kiosk Drop-Off Sites 1. Disposal Facility 1 • Name: Covanta Long Beach will incinerate Unwanted Medicine received from Transchem Environmental, LLC. • Address: 118 Pier S Ave, Long Beach, CA 90802 • Phone: (562) 436-0636 • Website: www.covantaes.com • Type: Municipal Solid Waste Combustor • Solid Waste Permit: 19-AK-0083. County of Los Angeles Public Health, Status: Issued • Title V Air Permit No: D47903. South Coast Air Quality Management District, Status: Issued • US EPA ID No: CAD982520066, Status: Issued • Penalty Record (5 years): None 2. Disposal Facility 2 • Name: Curtis Bay Energy, LP will incinerate Unwanted Medicine received from Doncin Transport, Inc. • Address: 3200 Hawkins Point Road Baltimore, MD 21226 • Phone: (855) 228-1715 • Website: www.curtisbayenergy.com • Type: Permitted Medical Waste Incinerator • Title V Air Permit No.: 24-510-02975, Status: Issued • Maryland Department of the Environment Refuse Disposal Permit No.: 2017-WMI-0036, Status: Issued • US EPA ID No.: MDD985404318, Status: Issued • Penalty Record (5 years): See Appendix K 3. Disposal Facility 3 • Name: Stericycle, Inc., Warren, Ohio Facility may incinerate Unwanted Medicine received from Stericycle Specialty Waste Solutions, Inc or United Parcel Service, Inc. • Address: 1901 Pine Avenue, S.E., Warren, OH 44483 • Phone: (330) 393-0370 • Website: https://www.stericycle.com/service-locations/ohio/warren • Type: Medical Waste Incinerator • DEA Registration No: RS0498130, Status: Issued • Solid Waste Operating Permit No: CID 41805, Status: Issued • Final Air Pollution Control Title V Permit No: P0115341, Status: Issued • Penalty Record (5 years): None 28 Standard Mail-Back Services I. Vendors for Standard Mail-Back Packages 1. Vendor 1 • Name: Stericycle Specialty Waste Solutions, Inc. may provide Standard Mail-Back Packages. • Address: 2850 100th Court NE, Blaine, MN 55449 • Phone: (612) 285-9865 • Website: www.stericycleenvironmental.com • US DOT No: 1348411, Status: Issued • DOT ID No: MNS 000 110 924, Status: Issued • Penalty Record (5 years): None 2. Vendor 2 • Name: Covanta Environmental Solutions, LLC may provide Standard Mail-Back Packages. • Address: 7326 E. Evans Road, Suite B, Scottsdale, AZ 85620 • Phone: (855) 269-1750 • Website: www.covantaes.com • DEA Registration No: RC0518160, Status: Issued • Penalty Record (5 years): None J. Carrier for Standard Mail-Back Packages • Name: United States Postal Service may ship Standard Mail-Back Packages to the Stericycle, Inc., Warren, Ohio Facility. United States Postal Service may also ship Standard Mail-Back Packages to the Covanta Manheim, Pennsylvania Facility. • Address: 475 L’Enfant Plaza, S.W. Washington, DC 20260 • Phone: (202) 268-2000 • Website: www.USPS.com/ • Type: Common Carrier • Penalty Record (5 years): For enforcement history, see USPS SEC filings K. Reverse Distributor Facilities and Transporter for Standard Mail-Back Packages 1. Reverse Distributor Facility • Name: Covanta Manheim, Pennsylvania Facility will receive Standard Mail-Back Packages from Covanta Environmental Solutions, LLC via United States Postal Service. • Address: 190 Shellyland Road, Manheim, PA 17545 • Phone: (717) 653-8882 • Website: www.covantaes.com • Type: DEA Registered Collector and Reverse Distributor • DEA Registration No: RC0322595, Status: Issued • Penalty Record (5 years): None 29 2. Transporter • Name: Doncin Transport, Inc. will transport Standard Mail-Back Packages from the Covanta Manheim, Pennsylvania Facility to Covanta Lancaster and/or Covanta York. • Address: 3478 Sunnyside Rd., Manheim, PA 17545 • Phone: (602) 344-4536 • Website: http://www.truckdrivingcdljobs.com/in/Pennsylvania/Manheim/DONCIN%20TRANSPORT%20INC.p hp • Type: Contract Carrier • US DOT Number: 001625457, Status: Issued • Penalty Record (5 years): None L. Disposal Facilities for Standard Mail-Back Packages 1. Disposal Facility 1 • Name: Stericycle, Inc. Warren, Ohio will incinerate Standard Mail-Back Packages received from United States Postal Service. • Address: 1901 Pine Avenue, S.E., Warren, OH 44483 • Phone: (330) 393-0370 • Website: www.stericycle.com/service-locations/ohio/warren • Type: Medical Waste Incinerator • DEA Registration No: RS0498130, Status: Issued • Solid Waste Operating Permit No: CID 41805, Status: Issued • Final Air Pollution Control Title V Permit No: P0115341, Status: Issued • Penalty Record (5 years): None 2. Disposal Facility 2 • Name: Covanta Lancaster will incinerate Standard Mail-Back Packages received from the Covanta Manheim, Pennsylvania Facility. • Address: 1911 River Road, Bainbridge, PA 17502 • Phone: (717) 397-9968 • Website: www.covanta.com • Type: Municipal Solid Waste Combustor • Solid Waste Permit: 400592 PaDEP, Status: Issued • Title V Operating Permit: 36-05013, Status: Issued • US EPA ID No: CAD982520066, Status: Issued • Penalty Record (5 years): None 3. Disposal Facility 3 • Name: Covanta York will incinerate Standard Mail-Back Packages received from the Covanta Manheim, Pennsylvania Facility. • Address: 2651 Blackbridge Road, York, PA 17406 • Phone: (717) 843-2902 • Website: www.covanta.com • Type: Municipal Solid Waste Combustor • Solid Waste Permit: 400561 PaDEP, Status: Issued • Title V Operating Permit: 67-05006, Status: Issued • Penalty Record (5 years): None 30 Inhaler Mail-Back Services M. Vendors for Inhaler Mail-Back Packages 1. Vendor 1 • Name: PureWay Compliance Inc. may provide Inhaler Mail-Back Packages. • Address: 20501 Katy Freeway, Suite 206, Katy, TX 77450 • Phone: (877) 765-3030 • Website: http://pureway.com/ • Penalty Record (5 years): None 2. Vendor 2 • Name: Stericycle Specialty Waste Solutions, Inc. may provide Inhaler Mail-Back Packages. • Address: 2850 100th Court NE, Blaine, MN 55449 • Phone: (612) 285-9865 • Website: www.stericycleenvironmental.com • US DOT No: 1348411, Status: Issued • DOT ID No: MNS 000 110 924, Status: Issued • Penalty Record (5 years): None N. Carriers for Inhaler Mail-Back Packages 1. Carrier 1 • Name: United Parcel Service, Inc. will transport Inhaler Mail-Back Packages provided by PureWay Compliance Inc. to Daniels Sharpsmart, Inc. Fresno, California Transfer Facility. • Address: 55 Glenlake Parkway NE, Atlanta, GA 30328 • Phone: (800) PICK-UPS • Website: www.UPS.com/ • Type: Common Carrier • U.S. Small Package DOT No: 21800, Status: Issued • U.S. Freight DOT No: 121058, Status: Issued • Penalty Record (5 years): For enforcement history, UPS advises that “all material government investigation and enforcement activity is provided in our SEC filings at investors.ups.com” 2. Carrier 2 • Name: United States Postal Service will transport Inhaler Mail-Back Packages provided by Stericycle to the Stericycle, Inc. Warren, Ohio Facility. • Address: 475 L’Enfant Plaza, S.W. Washington, DC 20260 • Phone: (202) 268-2000 • Website: www.USPS.com/ • Type: Common Carrier • Penalty Record (5 years): For enforcement history, see USPS SEC filings 31 O. Transfer Facility for Inhaler Mail-Back Packages • Name: Daniels Sharpsmart, Inc. Fresno, California Transfer Facility will receive Inhaler Mail-Back Packages provided by PureWay Compliance Inc. and provide for transport to the Covanta Huntsville, Inc. or Covanta Marion, Inc. Municipal Waste Combustors. • Address: 4144 East Therese Avenue, Fresno, CA 93725 • Phone: (559) 834-6252 • Website: http://danielsinternational.com/ • Type: Medical Waste Treatment Facility • Medical Waste Permit No: TS-OST-55, Status: Issued • CA EPA ID No: CAL000344393, Status: Issued • US DOT No: 1295076, Status: Issued • Penalty Record (5 years): See Appendix K P. Transporter(s) for Inhaler Mail-Back Packages 1. Transporter 1 • Name: Lula Logistics Inc. may transport Inhaler Mail-Back Packages provided by PureWay Compliance Inc. and received from the Daniels Sharpsmart, Inc. Fresno, California Transfer Facility to the Covanta Huntsville, Inc. or Covanta Marion, Inc. Municipal Waste Combustors. • Address: 8268 Nelson Ridge Ln, Las Vegas, NV 89178 • Phone: (352) 346-6219 • Email: https://www.lulalogisticsinc.com/ • Type: Contract Carrier • US DOT No: 2335002, Status: Issued • Penalty Record (5 years): None 2. Transporter 2 • Name: GPB Logistics Inc. may transport Inhaler Mail-Back Packages provided by PureWay Compliance Inc. and received from the Daniels Sharpsmart, Inc. Fresno, California Transfer Facility to the Covanta Huntsville, Inc. or Covanta Marion, Inc. Municipal Waste Combustors. • Address: 2115 W Farwell Ave #103, Chicago, IL 60645 • Phone: (773) 968-7210 • Website: www.gpblogistics.com • Type: Contract Carrier • US DOT No: 2783871, Status: Issued • Penalty Record (5 years): None Q. Disposal Facilities for Inhaler Mail-Back Packages 1. Disposal Facility 1 • Name: Covanta Huntsville, Inc. will incinerate Inhaler Mail-Back Packages provided by PureWay Compliance Inc. and received from Daniels Sharpsmart, Inc. Fresno, California Transfer Facility. • Address: 5251 Triana Blvd SW, Huntsville, AL 35805 • Phone: (256) 882-1019 • Website: https://www.covanta.com/Our-Facilities/Covanta-Huntsville • Type: Municipal Waste Combustor • Title V Air Permit No: 709-1104, Status: Issued • US EPA ID No: AL0000266726, Status: Issued • Penalty Record (5 years): None 32 2. Disposal Facility 2 • Name: Covanta Marion, Inc. will incinerate Inhaler Mail-Back Packages provided by PureWay Compliance Inc. and received from Daniels Sharpsmart, Inc. Fresno, California Transfer Facility. • Address: 4850 Brook Lake Rd. NE, Brooks, OR 97305 • Phone: (503) 393-0890 • Website: https://www.covanta.com/Our-Facilities/Covanta-marion • Type: Municipal Waste Combustor • Conditionally Exempt Small Quantity Generator: ORD987179470, Status: Issued • Title V Air Permit No: 24-5398-TV-01, Status: Issued • NPDES Permit No: 1200-Z, Status: Issued • Solid Waste Permit No: 364, Status: Issued • Penalty Record (5 years): None 3. Disposal Facility 3 • Name: Stericycle, Inc. Warren, Ohio will incinerate Inhaler Mail-Back Packages provided by Stericycle and received from the United States Postal Service. • Address: 1901 Pine Avenue, S.E., Warren, OH 44483 • Phone: (330) 393-0370 • Website: www.stericycle.com/service-locations/ohio/warren • Type: Medical Waste Incinerator • DEA Registration No: RS0498130, Status: Issued • Solid Waste Operating Permit No: CID 41805, Status: Issued • Final Air Pollution Control Title V Permit No: P0115341, Status: Issued • Penalty Record (5 years): None 33 Unwanted Medicine Educational and Outreach Programming A. Overview MED-Project will perform public education and outreach to educate Residents about the collection and disposal of Unwanted Medicine from households. B. Audiences To effectively educate the public about the Program, MED-Project will continue to implement a comprehensive communications campaign featuring both broad communications tactics as well as targeted outreach to audiences directly involved in the distribution and use of medicines to Residents. These audiences may include: • General public; • Pharmacies, including education for dispensers of Unwanted Medicine; • Retailers of Unwanted Medicine; • Health care providers and their patients; • Veterinary providers and animal owners; • Public health facilities; and/or • LEAs. The Program will include efforts to reach the varied cultural, linguistic, geographic, and age demographics, including through outreach to ethnic, community, and alternate-language media; outreach to community organizations serving a broad range of audiences; availability of alternate language phone lines (Section XI.D.1); and availability of educational information through a broad range of media platforms. Demographic information from the US Census Bureau, including race, ethnicity, language, age, and geographic data, will be analyzed in the survey (see Section XI.F) in order to appropriately direct outreach and create educational materials to best serve the unique needs of identified demographics. C. Messages MED-Project anticipates that messaging will: • Educate Residents about the appropriate use, storage, and disposal of Unwanted Medicine; • Educate Residents about available Mail-Back Services; and • Provide Residents with information about available locations and events in their area that offer disposal of Unwanted Medicine. Key points of emphasis might include: • The importance of taking medicines as prescribed by your health care provider; • The importance of adhering to and completing your provider-prescribed therapy; • The importance of properly and securely storing medicines; • The importance of promptly and properly disposing of Unwanted Medicine; • How to find and use Kiosk Drop-Off Sites; • How to properly dispose of Unwanted Medicine; and • Privacy issues (removing personally identifiable information from labeled prescription containers). 34 D. Tools/Communications Channels The MED-Project Program will include a number of components designed to reach consumers and provide consistent access to timely and relevant information. Distribution of materials will likely include audiences such as LEAs, retail pharmacies, health care providers and systems, health associations, local government agencies, and other community organizations. MED-Project will evaluate media and public outreach against the goal of a combined target reach percent of 50% at a 2+ frequency for the duration of one month, at least three times per year for years 2 through 4 of the Program. MED-Project intends to meet this target with a combination of digital media campaigns, print ads, and traditional broadcast media. The quantity and frequency will be confirmed as activities are completed. MED-Project expects that the tools and communication channels will include: 1. Phone The Program will provide a toll-free telephone number for Residents to obtain information about Kiosk Drop-Off Sites, Take-Back Events, Mail-Back Services, educational materials, and other aspects of the Program for the take-back of Unwanted Medicine from households. The toll-free number will provide: • Call Center in the Specified Languages. The telephone line will also provide an option for callers to be transferred to a staffed Call Center. • Basic information about the Program, such as where to obtain more information (e.g., the MED- Project Website) and an option to talk with an agent to find or utilize Kiosk Drop-Off Sites, Mail- Back Services, and/or Take-Back Events, if applicable, in the caller’s zip code or local area. • A recorded call script directing callers with medical emergencies to call 911 and directing callers with medication-related questions to contact their health care provider(s). Please see Appendix L for the call script. 2. MED-Project Website MED-Project will update the mobile-friendly MED-Project Website with translations in the Specified Languages. MED-Project expects information available to users will include pages to help Residents find locations of Kiosk Drop-Off Sites, Mail-Back Services, as well as educational materials, frequently asked questions and responses, and Take-Back Event dates and locations. • The Plan currently includes a mockup of the types of information a MED-Project Website and its supporting pages might contain. Appendix M provides a proof of concept example for a possible MED-Project Website with subpages. • The MED-Project Website may also include access to a public relations toolkit in a downloadable format (see Section XI.D.3) and contact information for Residents. A toolkit could include items such as a flyer/brochure (See Appendix N for an example) and a frequently asked questions (FAQ) document. Translations of the brochure and FAQ will be available in the Specified Languages. • Community and government organizations and other public interest groups seeking materials to promote the Program will be encouraged to access these resources. 35 3. Materials Educational materials about the Program and how to properly dispose of Unwanted Medicine will be available through the MED-Project Website, through potential third-party partners, community organizations, and at Kiosk Drop-Off Sites. The Plan includes the information and educational brochure (Appendix N). Educational materials will use plain language and explanatory images to promote consumer education and collection options to Residents with limited English proficiency. 4. Social Media MED-Project will continue the social media campaign consisting of Facebook and Twitter. These social media portals (Appendix O) are used to communicate the latest information to Residents. Outreach is based on the establishment of Kiosk Drop-Off Sites and the scheduling of Take-Back Events. Posts are scheduled on a weekly basis to reflect the most up-to-date information available. 5. Broadcast Outreach Outreach through local print, online, radio, and television outlets, including through outlets specifically targeting the diverse demographic communities within the County, will continue upon Plan approval. Please see Appendix F for a media list of key outlets. Broadcast outreach will be scheduled on a quarterly basis to reflect real time implementation developments. E. Collaboration with County Officials and Community Organizations MED-Project expects that the Program will work in collaboration with the County as appropriate to build on existing community outreach resources, such as local organizations, media lists, available public media outlets, etc. Activities like the following will continue upon Plan approval: • Briefing Materials Provided to Support Coordination with County Officials: o The Program will provide access to updated educational and outreach materials, including the brochure (see Appendix N), to relevant departments and officials. • Outreach through Community Organizations: o The Program will engage relevant stakeholders and community organizations by providing selected community organizations identified in Appendix B with the updated brochure included in Appendix N. F. Effectiveness MED-Project will conduct a biennial survey of Residents and pharmacists, veterinarians, and health professionals in the County who interact with patients to measure Program awareness and to evaluate the effectiveness of its education and outreach activities. The survey will be conducted in conjunction with the biennial survey conducted under MED-Project’s stewardship program for the collection of sharps from households. The first survey will be conducted after the first full year of operation of MED-Project’s program for sharps. G. Disclaimer The written and verbal educational materials and public outreach tools that are required by the Ordinance and disseminated under this Product Stewardship Plan will include a disclaimer similar to the following: “This material has been provided for the purpose of compliance with legislation and does not necessarily reflect the views of MED-Project or the Producers participating in the MED-Project Product Stewardship Plan.” 36 Compliance with Applicable Laws, Regulations, and other Legal Requirements As described in more detail below, the Plan is designed such that all entities participating in the Program shall comply with all applicable laws, regulations, and other legal requirements. A. DEA Controlled Substances Act and Implementing Regulations On October 12, 2010, the United States Congress enacted the Secure and Responsible Drug Disposal Act of 2010 (“Disposal Act”) as amendments to the Controlled Substances Act (“CSA”). The Disposal Act amended the CSA to allow for the expansion of entities to which users can deliver pharmaceutical controlled substances for disposal, subject to regulations to be promulgated. On September 9, 2014, the DEA adopted a rule entitled “Disposal of Controlled Substances” (referred to herein as the “DEA Rule”) to implement the Disposal Act. Under the DEA Rule, collection of controlled substances is limited to Schedule II, III, IV, or V controlled substances that are lawfully possessed by an ultimate user or person entitled to dispose of an ultimate user decedent’s property. See DEA Rule §§ 1317.75(b) (Kiosk Drop-Off Sites)5; 1317.65(d) (Take-Back Events); 1317.70(b) (Mail-Back Services). Schedule I controlled substances, controlled substances that are not lawfully possessed as described above, and other illicit or dangerous substances will not be collected. Additionally, as these provisions of the DEA Rule limit collection of controlled substances to those lawfully possessed by an ultimate user or certain other persons, pharmacies are prohibited from disposing their own inventory or stock through the MED-Project Program. See also DEA Rule § 1317.05. The DEA Rule provides that LEAs can continue to accept controlled substances for disposal. However, the DEA Rule also provides that pharmacies, reverse distributors, hospitals/clinics with on-site pharmacies, and certain other entities, can register with the DEA as “collectors” and become authorized at their discretion on a voluntary basis to accept controlled substances. The DEA Rule: • Provides for the collection of controlled substances at Kiosk Drop-Off Sites at LEAs, pharmacies, and hospitals with on-site pharmacies; • Provides for collection of controlled substances at Take-Back Events; • Provides for the use of mail-back programs to collect controlled substances; • Allows for the commingling of controlled and non-controlled substances; • Establishes detailed collection, recordkeeping, security, and other measures for all approved collection methods; and • Provides that all collected pharmaceutical products be destroyed so that the products are rendered non-retrievable. The Plan is designed such that all entities that are part of the Program, including Vendor, are individually responsible to comply with their respective compliance obligations under the DEA Rule. Vendor will ensure that the collection, transportation, and disposal of Unwanted Medicine collected from Kiosk Drop-Off Sites, Mail-Back Services, and Take-Back Events, including controlled substances, complies with all DEA requirements, including those in DEA Rule § 1317. Controlled substances collected pursuant to the Plan may be commingled with non-controlled substances at Kiosk Drop-Off Sites, Take-Back Events, and through Mail-Back Services per the DEA Rule. See DEA Rule §§ 1317.75(b) (Kiosk Drop-Off Sites); 1317.65(d) (Take-Back Events); 1317.70(b) (Mail-Back Services). 5 For Kiosk Drop-Off Site collection, only certain substances “that are lawfully possessed by an ultimate user or other authorized non-registrant person may be collected.” DEA Rule § 1317.75(b). This language is similar to, but slightly different than, provisions limiting collection at Take-Back Events and through Mail-Back Services to ultimate users or other persons (lawfully) entitled to dispose of an ultimate user decedent’s property. See DEA Rule §§ 1317.65(d); 1317.70(b). 37 1. DEA Registration Modification Pursuant to DEA Rule § 1301.51(b), pharmacies may modify their registrations to become authorized collectors by submitting a written request to the DEA or online at www.DEAdiversion.usdoj.gov. This request must contain: • The registrant’s name, address, and registration number (as printed on the registration certificate); • The collection methods the registrant intends to conduct; and • A signature in accordance with 21 C.F.R. § 1301.13(j). See DEA Rule § 1301.51(b). MED-Project will consult with participating pharmacies, as requested, regarding how to modify DEA registrations to become authorized collectors. B. United States Department of Transportation (DOT) When preparing Unwanted Medicine for transport and transporting Unwanted Medicine, Vendor or the Host-Assisted Collection Kiosk Drop Off-Site will ensure compliance with the DOT Hazardous Materials Regulations (HMR). C. California Board of Pharmacy On June 8, 2017, the Board of Pharmacy adopted the Board of Pharmacy Regulations, Article 9.1 of Division 17 of Title 16 of the California Code of Regulations. Largely based on the DEA Rule, the Board of Pharmacy Regulations establish requirements applicable to pharmacies, hospitals/clinics with on-site pharmacies, distributors, and reverse distributors conducting certain drug take-back services. Among other things, the Board of Pharmacy Regulations provide: • That California-licensed pharmacies and hospitals/clinics with on-site pharmacies must be in good standing with, and notify, the Board of Pharmacy to host a drug kiosk. See 16 CCR §§ 1776, 1776.1(i). • That pharmacies must “know and adhere” to all applicable “federal, state, and local requirements governing the collection and destruction of dangerous drugs” when operating a drug take-back program. See 16 CCR § 1776.1(b). • Drug kiosk placement and monitoring requirements. See 16 CCR §§ 1776.3(b)–(d). • Drug kiosk inner liner, container, and signage requirements. See 16 CCR §§ 1776.3(f), (h), (m). • Inner liner handling, storage, and destruction requirements for drug kiosks. See, e.g., 16 CCR §§ 1776.3(h)–(j), 1776.5(a)–(c). • Pharmacy and reverse distributor recordkeeping requirements. See 16 CCR §§ 1776.5(e)–(f), 1776.6. • Pharmacy drug mail-back program requirements. See 16 CCR § 1776.2. The Plan is designed such that all entities that are part of the Program, including Vendor, are individually responsible for complying with their respective compliance obligations under the Board of Pharmacy Regulations. Annual Report An annual report will be provided to the Director on or before the date set by the Department and annually thereafter. Ordinance § 6.53.080. This report will be provided in the format required by the Ordinance § 6.53.080 and Regulations § 15. The total amount by weight collected by a Mail-Back Program will be provided using an average weight per Mail-Back Package, as provided by Vendor. 38 Appendix A MED-Project Participants The list of participating Producers in MED-Project’s Program in the County is provided to the County on a periodic basis to satisfy Ordinance requirements. 39 Appendix B Contact List for Outreach and Education to the Community The following are Associations, Agencies, and Organizations that may be contacted for assistance with outreach and education to the community. Health Systems: Alameda County Medical Center Alameda Hospital Alta Bates Summit Medical Center Children’s Hospital and Research Center Eden Medical Center Fremont Hospital Kaiser Foundation Hospital Kindred Hospital Mpi Chemical Dependency Recovery Hospital San Leandro Hospital St. Rose Hospital Telecare Heritage Psychiatric Health Facility Telecare Willow Rock Center Thunder Road Chemical Dependency Recovery Hospital Valley Memorial Hospital Valleycare Medical Center Washington Hospital Health Associations and Societies: California State Board of Pharmacy California Pharmacists Association The Medical Board of California California Nurses Association National Association of Social Workers California Chapter California Board of Registered Nursing California Board of Vocational Nursing California Department of Health Care Services California Health and Human Services Agency Alameda-Contra Costa Medical Association Organizations, Districts, and Agencies: Alameda County Public Health Department Alameda County Department of Environmental Health Alameda County Public Works Agency Health Program of Alameda County Alameda County Board of Supervisors Alameda County Fire Department American Medical Response Alameda County CalRecycle Recyclewhere.org 40 Appendix C Interested Sites and Participating Kiosk Drop-Off Sites MED-Project will provide the County with a list of participating Kiosk Drop-Off Sites on a periodic basis. Site Name Address City Zip Code Status ALAMEDA HOSPITAL 2070 CLINTON AVENUE ALAMEDA 94501 ACTIVE ALAMEDA POLICE DEPARTMENT 1555 OAK ST. ALAMEDA 94501 ACTIVE SITE BART POLICE DEPARTMENT 101 8TH ST OAKLAND 94607 ACTIVE SITE BERKELEY POLICE DEPARTMENT 2100 MARTIN LUTHER KING JR. WAY BERKELEY 94704 ACTIVE SITE CAPSULE PHARMACY 2557 MOWRY AVE FREMONT 94538 ACTIVE SITE CITY OF NEWARK POLICE DEPARTMENT 37101 NEWARK ST. NEWARK 94560 ACTIVE SITE CVS/PHARMACY #0331 2000 DRISCOLL RD FREMONT 94539 ACTIVE SITE CVS/PHARMACY #0414 14869 E 14TH ST SAN LEANDRO 94578 ACTIVE SITE CVS/PHARMACY #0816 22501 FOOTHILL BLVD HAYWARD 94541 ACTIVE SITE CVS/PHARMACY #09397 4405 1ST ST LIVERMORE 94551 ACTIVE SITE CVS/PHARMACY #09494 35080 NEWARK BLVD NEWARK 94560 ACTIVE SITE CVS/PHARMACY #09553 4349 SAN PABLO AVENUE EMERYVILLE 94608 ACTIVE SITE CVS/PHARMACY #09600 35720 FREMONT BLVD FREMONT 94536 ACTIVE SITE CVS/PHARMACY #09622 243 W JACKSON ST HAYWARD 94544 ACTIVE SITE CVS/PHARMACY #09635 1550 E 14TH STREET SAN LEANDRO 94577 ACTIVE SITE CVS/PHARMACY #09678 1500 1ST ST LIVERMORE 94550 ACTIVE SITE CVS/PHARMACY #09876 699 LEWELLING BLVD SAN LEANDRO 94579 ACTIVE SITE 41 Site Name Address City Zip Code Status CVS/PHARMACY #09904 3667 CASTRO VALLEY BLVD CASTRO VALLEY 94546 ACTIVE SITE CVS/PHARMACY #09941 1451 SHATTUCK AVE BERKELEY 94709 ACTIVE SITE CVS/PHARMACY #09942 1401 WASHINGTON AVE SAN LEANDRO 94577 ACTIVE SITE CVS/PHARMACY #09957 344 THOMAS L BERKLEY WAY OAKLAND 94612 ACTIVE SITE CVS/PHARMACY #10119 6750 BERNAL AVE PLEASANTON 94566 ACTIVE SITE CVS/PHARMACY #10121 2655 TELEGRAPH AVE BERKELEY 94704 ACTIVE SITE CVS/PHARMACY #10199 26059 MISSION BLVD HAYWARD 94544 ACTIVE SITE CVS/PHARMACY #10475 2964 BROADWAY OAKLAND 94611 ACTIVE SITE CVS/PHARMACY #10924 3010 BERNAL AVE PLEASANTON 94566 ACTIVE SITE CVS/PHARMACY #3024 7201 REGIONAL ST DUBLIN 94568 ACTIVE SITE CVS/PHARMACY #3026 2300 SHATTUCK AVE BERKELEY 94704 ACTIVE SITE CVS/PHARMACY #8431 7200 BANCROFT AVE OAKLAND 94605 ACTIVE SITE CVS/PHARMACY #9099 4020 FREMONT HUB FREMONT 94538 ACTIVE SITE CVS/PHARMACY #9128 2314 SANTA CLARA AVE ALAMEDA 94501 ACTIVE SITE CVS/PHARMACY #9130 175 41ST ST OAKLAND 94611 ACTIVE SITE CVS/PHARMACY #9226 3320 FRUITVALE AVE OAKLAND 94602 ACTIVE SITE CVS/PHARMACY #9234 46445 MISSION BLVD FREMONT 94539 ACTIVE SITE CVS/PHARMACY #9250 885 ISLAND DR STE A ALAMEDA 94502 ACTIVE SITE CVS/PHARMACY #9251 3999 SANTA RITA ROAD PLEASANTON 94588 ACTIVE SITE CVS/PHARMACY #9255 931 MARINA VILLAGE PKWY ALAMEDA 94501 ACTIVE SITE CVS/PHARMACY #9378 4100 REDWOOD RD OAKLAND 94619 ACTIVE SITE DUBLIN POLICE SERVICES 100 CIVIC PLAZA DUBLIN 94568 ACTIVE SITE 42 Site Name Address City Zip Code Status EDEN HOSPITAL (1ST KIOSK) 20103 LAKE CHABOT ROAD CASTRO VALLEY 94546 INTERESTED EDEN HOSPITAL (2ND KIOSK) 20103 LAKE CHABOT ROAD CASTRO VALLEY 94546 INTERESTED EMERYVILLE POLICE DEPARTMENT 2449 POWELL ST EMERYVILLE 94608 ACTIVE SITE HALLER'S PHARMACY AND MEDICAL SUPPLY 37323 FREMONT BLVD. FREMONT 94536 ACTIVE SITE HIGHLAND HOSPITAL OUTPATIENT PHARMACY (1ST KIOSK) 1411 E 31ST ST OAKLAND 94602 ACTIVE SITE HIGHLAND HOSPITAL OUTPATIENT PHARMACY (2ND KIOSK) 1411 E 31ST ST OAKLAND 94602 ACTIVE SITE JADE PHARMACY 34460 FREMONT BLVD, SUITE B FREMONT 94555 ACTIVE SITE KAISER FDN HLT PLAN FABIOLA 1 PHY 115 3801 HOWE ST. OAKLAND 94511 ACTIVE SITE KAISER HEALTH PLAN OHLONE PHY 162 39400 PASEO PADRE PKWAY FREMONT 94538 ACTIVE SITE KAISER HEALTH PLAN PEDIATRIC PHY 118 3505 BROADWAY OAKLAND 94611 ACTIVE SITE KAISER HEALTH PLAN SOUTH 1 PHY 471 7601 STONERIDGE PLEASANTON 94588 ACTIVE SITE KAISER PERMANENTE PHARMACY #102 3701 BROADWAY OAKLAND 94611 ACTIVE SITE KAISER PERMANENTE PHARMACY #105 3600 BROADWAY OAKLAND 94611 ACTIVE SITE KAISER PERMANENTE PHARMACY #241 3000 LOS POSITAS LIVERMORE 94551 ACTIVE SITE 43 Site Name Address City Zip Code Status KAISER PERMANENTE PHARMACY NO 101 2417 CENTRAL AVE. ALAMEDA 94501 ACTIVE SITE KAISER UNION CITY MAIN MOB 2 PHY #132 3553 WHIPPLE RD. UNION CITY 94587 ACTIVE SITE MISSION PHARMACY 22138 MISSION BLVD. HAYWARD 94541 ACTIVE SITE MOWRY MEDICAL PHARMACY 1999 MOWRY AVE., STE A FREMONT 94538 ACTIVE SITE NEW OAKLAND PHARMACY - LAKE MERRITT 250 E. 18TH ST. OAKLAND 94606 ACTIVE SITE NEW OAKLAND PHARMACY #2 388 9TH ST. OAKLAND 94607 ACTIVE SITE NEW OAKLAND PHARMACY_#1 333 9TH ST. OAKLAND 94607 ACTIVE SITE PIEDMONT POLICE DEPARTMENT 403 HIGHLAND AVE PIEDMONT 94611 ACTIVE SITE PLEASANTON POLICE DEPARTMENT 4833 BERNAL AVE. PLEASANTON 94566 ACTIVE SITE RITE AID 05918 3744 MOWRY AVENUE FREMONT 94538 INTERESTED RITE AID 05920 31091 MISSION BOULEVARD HAYWARD 94544 INTERESTED RITE AID 05922 3848 CASTRO VALLEY BOULEVARD CASTRO VALLEY 94546 INTERESTED RITE AID 05925 968 MURRIETA BOULEVARD LIVERMORE 94550 INTERESTED RITE AID 05937 1355 MACARTHUR BOULEVARD SAN LEANDRO 94577 INTERESTED RITE AID 05942 31836 ALVARADO BOULEVARD UNION CITY 94587 INTERESTED RITE AID 05943 1650 DECOTO ROAD UNION CITY 94587 INTERESTED 44 Site Name Address City Zip Code Status RITE AID 05944 2819 HOPYARD ROAD PLEASANTON 94588 INTERESTED RITE AID 05952 1991 MOUNTAIN BOULEVARD OAKLAND 94611 INTERESTED RITE AID 06456 1350 NORTH VASCO ROAD LIVERMORE 94551 INTERESTED SAN LEANDRO HOSPITAL 13855 EAST 14TH ST SAN LEANDRO 94578 ACTIVE SITE STANFORD EMERYVILLE HEALTH CENTER PHARMACY 5800 HOLLIS ST. EMERYVILLE 94608 ACTIVE SITE TEDS DRUGS 27453 HESPERIAN HAYWARD 94545 ACTIVE SITE TENNYSON PHARMACY 589 W. TENNYSON HAYWARD 94544 ACTIVE SITE UNITED PHARMACY 2929 TELEGRAPH AVE BERKELEY 94705 ACTIVE SITE VITACARE PHARMACY 2775 TELEGRAPH AVE OAKLAND 94612 ACTIVE SITE WASHINGTON HOSPITAL PHARMACY 2000 MOWRY AVE FREMONT 94538 ACTIVE SITE WELLSPRING PHARMACY 4184 C PIEDMONT AVE OAKLAND 94611 ACTIVE SITE 45 Appendix D Potential Additional Kiosk Drop-Off Sites Site Name Address City Zip AHF PHARMACY 400 THIRTIETH ST STE 300 OAKLAND 94609 ALAMEDA PHARMACY LLC 1555 DOOLITTLE DRIVE #160 SAN LEANDRO 94577 ALTA BATES SUMMIT MED CTR-HERRICK CAMPUS 2001 DWIGHT WY BERKELEY 94704 ALTA BATES SUMMIT MEDICAL CENTER - ALTA BATES CAMPUS 2450 ASHBY AVE BERKELEY 94705 ALTA BATES SUMMIT MEDICAL CENTER - SUMMIT CAMPUS 350 HAWTHORNE AVE OAKLAND 94609 ALTA BATES SUMMIT OUTPATIENT PHARMACY 2001 DWIGHT WAY STE 2182 BERKELEY 94704 BRADFORD PHARMACY INC. 445 8TH STREET OAKLAND 94607 CALIFORNIA STATE UNIVERSITY, EAST BAY 25800 CARLOS BEE BLVD HAYWARD 94542 CENTRAL ADMIXTURE PHARMACY SERVICES INC 48006 FREMONT BLVD FREMONT 94538 CHILDREN'S HOSPITAL & RESEARCH CENTER AT OAKLAND 747 52ND ST OAKLAND 94609 CHILDREN'S HSP MED CTR AMBULATORY CARE 744 52ND ST OAKLAND 94609 CHILDRENS CLINIC PHARMACY 747 52ND STREET OAKLAND 94609 CLEAR CHOICE PHARMACY 3059 HOPYARD RD STE C PLEASANTON 94588 COMMUNITY A WALGREENS PHARMACY #16477 3009 BROADWAY OAKLAND 94611 CORAM CVS/SPECIALTY INFUSION SERVICES 3160 CORPORATE PLACE HAYWARD 94545 COSTCO PHARMACY #1061 28505 HESPERIAN BLVD HAYWARD 94545 COSTCO PHARMACY #146 2800 INDEPENDENCE DRIVE LIVERMORE 94550 COSTCO PHARMACY #778 43621 PACIFIC COMMONS BLVD FREMONT 94538 46 COSTCO PHARMACY 118 1900 DAVIS STREET SAN LEANDRO 94577 CPP PET CARE 3157 CORPORATE PL HAYWARD 94545 CRESCENT HEALTHCARE 2547 BARRINGTON CT HAYWARD 94545 CVS/PHARMACY # 16116 7200 AMADOR PLAZA RD DUBLIN 94568 CVS/PHARMACY # 16275 4300 LAS POSITAS RD LIVERMORE 94551 CVS/PHARMACY # 16764 15555 E 14TH ST STE 400 SAN LEANDRO 94578 CVS/PHARMACY # 16804 2499 WHIPPLE RD HAYWARD 94544 CVS/PHARMACY # 17044 1057 ESTSHORE HWY ALBANY 94710 CVS/PHARMACY # 17265 19661 HESPERIAN BLVD HAYWARD 94541 CVS/PHARMACY # 17592 43950 PACIFIC COMMONS BLVD FREMONT 94538 CVS/PHARMACY # 17624 1555 40TH STREET EMERYVILLE 94608 CVS/PHARMACY # 17628 2800 DUBLIN BLVD DUBLIN 94568 CVS/PHARMACY # 17657 2700 5TH ST ALAMEDA 94501 CVS/PHARMACY # 17673 2187 SHATTUCK AVE BERKELEY 94704 DOLPHIN HEALTH PHARMACY 7400 MACARTHUR BLVD NO A OAKLAND 94605 DRATE PHARMACY 3219 ADELINE STREET BERKELEY 94703 EAST BAY AIDS CENTER OUTPATIENT PHARMACY 3100 SUMMIT ST OAKLAND 94609 ENTIRELYPETS PHARMACY 34571 SEVENTH ST UNION CITY 94587 FAIRMONT HOSPITAL PHARMACY 15400 FOOTHILL BOULEVARD SAN LEANDRO 94578 FOODMAXX PHARMACY #484 3100 EAST 9TH ST OAKLAND 94601 FREMONT HOSPITAL 39001 SUNDALE DR FREMONT 94538 FRUITVALE AVENUE PHARMACY 2693 FRUITVALE AVE OAKLAND 94601 47 GARFIELD BEACH CVS LLC CVS/PHARMACY #10475 2964 BROADWAY OAKLAND 94611 GARFIELD BEACH CVS LLC D/B/A CVS/PHARMACY # 17712 1414 UNIVERSITY AVE BERKELEY 94702 HALLER'S LTC PHARMACY 4067 PERALTA BLVD FREMONT 94536 HAYWARD SISTERS HOSPITAL DBA ST ROSE HOSPITAL 27200 CALAROGA AVE RM A1- 108 HAYWARD 94545 HERRICK CAMPUS PHARMACY 2100 DWIGHT WAY RM 2113 BERKELEY 94704 HIGH STREET PHARMACY 4248 MACARTHUR BLVD OAKLAND 94619 INTEGRATED MEDICAL ASSOCIATES PHARMACY INC 10500 MACARTHUR BLVD #103 OAKLAND 94605 JOHN GEORGE PSYCHIATRIC PAVILION PHY 2060 FAIRMONT DRIVE SAN LEANDRO 94578 KAISER FDN HSP INP PHY 16A 39400 PASEO PADRE PARKWAY FREMONT 94538 KAISER FOUNDATION CPP PHARMACY 251 300 G PULLMAN STREET LIVERMORE 94550 KAISER FOUNDATION HOSPITAL PHARMACY #10A 275 W MACARTHUR BLVD OAKLAND 94611 KAISER FOUNDATION HOSPITAL PHARMACY #92A 2500 MERCED ST HOSPITAL BLDG SAN LEANDRO 94577 KAISER FOUNDATION HOSPITAL PHY #47B 7601 STONERIDGE DR RM 218 PLEASANTON 94588 KAISER HEALTH PLAN NILES 3 PHY 164 39400 PASEO PADRE PARKWAY FREMONT 94538 KAISER HEALTH PLAN NILES PHY 161 39400 PASEO PADRE PARKWAY FREMONT 94538 KAISER HEALTH PLAN NORTH 1 PHY 473 5600 STONERIDGE MALL ROAD PLEASANTON 94588 KAISER HEALTH PLAN SOUTH 2 PHY 472 7601 STONERIDGE DR PLEASANTON 94588 KAISER HLTH PLAN SLEEPY HOLLOW PHY 143 27303 SLEEPY HOLLOW AVENUE SOUTH HAYWARD 94545 KAISER ONCOLOGY PHARMACY #104 3701 BROADWAY FLR 3 OAKLAND 94611 KAISER ONCOLOGY PHARMACY #165 39400 PASEO PADRE PKWY NILES BLDG 2ND FL FREMONT 94538 48 KAISER PERMANENTE PHARMACY #181 1795 SECOND ST, SUITE B BERKELEY 94710 KAISER PERMANENTE PHARMACY #921 2500 MERCED ST FL 1 SAN LEANDRO 94577 KAISER PERMANENTE PHARMACY #922 2500 MERCED ST 2ND FL RM 2966 SAN LEANDRO 94577 KINDRED HSP-SAN FRANCISCO BAY 2800 BENEDICT DR SAN LEANDRO 94577 LA CLINICA DE LA RAZA 3451 E 12TH ST OAKLAND 94601 LA CLINICA DE LA RAZA, INC. 1030 INTERNATIONAL BLVD OAKLAND 94606 LIFESCRIPT PHARMACY 7700 EDGEWATER DR #220 OAKLAND 94621 LIRX 1860 MOWRY AVE STE 102 FREMONT 94538 LUCKY PHARMACY #711 40055 MISSION BLVD FREMONT 94539 LUCKY PHARMACY #712 34101 FREMONT BLVD FREMONT 94555 LUCKY PHARMACY #714 5000 MOWRY AVE FREMONT 94538 LUCKY PHARMACY #715 22555 MISSION BLVD HAYWARD 94541 LUCKY PHARMACY #716 25151 SANTA CLARA ST HAYWARD 94544 LUCKY PHARMACY #721 2000 PORTOLA AVE LIVERMORE 94550 LUCKY PHARMACY #722 1951 HOLMES ST LIVERMORE 94550 LUCKY PHARMACY #736 247 E 18TH ST OAKLAND 94606 LUCKY PHARMACY #744 6155 W LAS POSITAS BLVD PLEASANTON 94588 LUCKY PHARMACY #767 1300 FAIRMONT DR SAN LEANDRO 94578 LUCKY PHARMACY #768 15840 HESPERIAN BLVD SAN LORENZO 94580 LUCKY PHARMACY #782 32300 DYER ST UNION CITY 94587 MASONIC HOME PHARMACY 34400 MISSION BLVD UNION CITY 94587 MAXOR CORRECTIONAL PHARMACY SERVICES C/O SANTA RITA JAIL DUBLIN 94568 49 MAXOR CORRECTIONAL PHARMACY SERVICES C/O GLENN DYER DETENTION FACILITY OAKLAND 94607 MEDICAL ARTS PHARMACY 13847 E 14TH ST STE 103 SAN LEANDRO 94578 MOWRY PLAZA PHARMACY 668 MOWRY AVE FREMONT 94536 MY LAN PHARMACY 401 EAST 18TH STREET - SUITE B OAKLAND 94606 NEW CHINA TOWN PHARMACY 719 EAST 12TH STREET OAKLAND 94606 NEW TIBURCIO VASQUEZ HEALTH CENTER PHY 33255 9TH STREET UNION CITY 94587 NICHOLS HILL PRESCRIPTION PHARMACY 2844 SUMMIT STREET OAKLAND 94609 OAKLAND CLINIC PHARMACY 5220 CLAREMONT AVE OAKLAND 94618 OMNICARE OF HAYWARD 20967 CABOT BLVD HAYWARD 94545 PACIFIC PHARMACY 650 INTERNATIONAL BLVD OAKLAND 94606 PERALTA OUTPATIENT PHARMACY 3300 WEBSTER ST, GROUND FL OAKLAND 94609 PHARMACA INTEGRATIVE PHARMACY INC 5729 COLLEGE AVE OAKLAND 94618 PHARMACA INTEGRATIVE PHARMACY INC 1744 SOLANO AVE BERKELEY 94707 PHARMERICA 32980 ALVARADO NILES RD STE 836 UNION CITY 94587 PLEASANT CARE PHARMACY 1652 B ST HAYWARD 94541 RALEYS PHARMACY #315 39200 PASEO PADRE PARKWAY FREMONT 94538 RALEYS PHARMACY #316 5420 SUNOL BLVD. PLEASANTON 94566 REDWOOD LTC PHARMACY 3160 CASTRO VALLEY BLVD STE 101 CASTRO VALLEY 94546 SAFEWAY PHARMACY #0676 1500 SOLANO AVE ALBANY 94706 SAFEWAY PHARMACY #0691 1444 SHATTUCK PLACE BERKELEY 94709 SAFEWAY PHARMACY #0768 20629 REDWOOD RD CASTRO VALLEY 94546 50 SAFEWAY PHARMACY #0908 3550 FRUITVALE AVE OAKLAND 94602 SAFEWAY PHARMACY #0951 867 ISLAND DR ALAMEDA 94502 SAFEWAY PHARMACY #0971 22280 FOOTHILLS BLVD HAYWARD 94541 SAFEWAY PHARMACY #0993 3902 WASHINGTON BLVD FREMONT 94538 SAFEWAY PHARMACY #1197 1790 DECOTO RD UNION CITY 94587 SAFEWAY PHARMACY #1257 4495 FIRST ST LIVERMORE 94551 SAFEWAY PHARMACY #1931 46848 MISSION BLVD FREMONT 94539 SAFEWAY PHARMACY #1932 4440 TASSAJARA RD DUBLIN 94568 SAFEWAY PHARMACY #1953 7499 DUBLIN BLVD DUBLIN 94568 SAFEWAY PHARMACY #2708 2227 S SHORE CENTER ALAMEDA 94501 SAFEWAY PHARMACY #2856 6790 BERNAL AVE PLEASANTON 94566 SAFEWAY PHARMACY #2870 6310 COLLEGE AVE OAKLAND 94618 SAFEWAY PHARMACY #3125 3889 SAN PABLO AVE EMERYVILLE 94608 SAFEWAY PHARMACY #3132 5100 BROADWAY OAKLAND 94611 SAFEWAY PHARMACY #3281 2600 5TH ST ALAMEDA 94501 SKILLED NURSING PHARMACY 21150 CABOT BLVD HAYWARD 94545 SOLEO HEALTH INC 1324 W WINTON AVE HAYWARD 94545 STONERIDGE PROFESSIONAL PHARMACY 5720 STONERIDGE MALL RD STE 150 PLEASANTON 94588 SUTTER INFUSION & PHARMACY SERVICES 1105 ATLANTIC AVE STE 102 ALAMEDA 94501 TIB PHARMACY LLC 5886 MOWRY SCHOOL RD NEWARK 94560 UNIVERSITY HEALTH SERVICE PHARMACY 2222 BANCROFT AVE RM 1115 BERKELEY 94702 VALLEY MEMORIAL HOSPITAL PHARMACY 1111 EAST STANLEY BOULEVARD LIVERMORE 94550 VALLEYCARE MEDICAL CENTER PHARMACY 5555 W LAS POSITAS BLVD 1ST FL PLEASANTON 94588 51 VERSAILLES PHARMACY 2801 ENCINAL ALAMEDA 94501 VIBRANT CARE PHARMACY INC 7400 MACARTHUR BLVD STE B OAKLAND 94605 WAL MART PHARMACY 10 2031 30600 DYER STREET UNION CITY 94587 WAL-MART PHARMACY 10-1972 2700 LAS POSITAS RD LIVERMORE 94551 WAL-MART PHARMACY 10-5434 15555 HESPERIAN BLVD SAN LEANDRO 94579 WAL-MART PHARMACY 10-5611 3112 SANTA RITA RD PLEASANTON 94566 WALGREEN CO D/B/A WALGREENS #15330 5809 FOOTHILL BLVD OAKLAND 94605 WALGREENS #00101 3382 CASTRO VALLEY BLVD CASTRO VALLEY 94546 WALGREENS #01536 3434 HIGH STREET OAKLAND 94619 WALGREENS #01537 3232 FOOTHILL BLVD OAKLAND 94601 WALGREENS #01625 5055 TELEGRAPH AVE OAKLAND 94609 WALGREENS #02150 1763 SANTA RITA RD PLEASANTON 94566 WALGREENS #02306 1138 W TENNYSON_RD HAYWARD 94544 WALGREENS #02314 1050 GILMAN ST BERKELEY 94710 WALGREENS #02366 3860 DECOTO ROAD FREMONT 94555 WALGREENS #02401 21463 FOOTHILL BLVD HAYWARD 94541 WALGREENS #02426 15500 WASHINGTON AVE SAN LEANDRO 94579 WALGREENS #02609 2995 SAN PABLO AVE BERKELEY 94702 WALGREENS #02660 41400 BLACOW RD FREMONT 94538 WALGREENS #03170 3400 TELEGRAPH AVE OAKLAND 94609 WALGREENS #03295 8102 INTERNATIONAL BLVD OAKLAND 94621 WALGREENS #04050 1916 WEBSTER ST ALAMEDA 94501 WALGREENS #04517 2600 MOWRY AVE FREMONT 94538 52 WALGREENS #04614 2801 ADELINE ST BERKELEY 94703 WALGREENS #04659 164 W JACKSON ST HAYWARD 94544 WALGREENS #06502 23958 HESPERIAN BLVD HAYWARD 94541 WALGREENS #07274 1456 136TH AVE SAN LEANDRO 94578 WALGREENS #09248 2300 OTIS DRIVE ALAMEDA 94501 WALGREENS #10045 2310 TELEGRAPH AVE BERKELEY 94704 WALGREENS #10526 3250 LAKESHORE AVE SUITE B OAKLAND 94610 WALGREENS #11706 301 EAST 18TH STREET OAKLAND 94606 WALGREENS #13595 1333 BROADWAY OAKLAND 94612 WALGREENS #13858 1607 SHATTUCK AVE BERKELEY 94709 WALGREENS #15025 2190 SHATTUCK AVE BERKELEY 94704 WALGREENS #15163 1620 FIRST STREET LIVERMORE 94550 WALGREENS #15666 1600 PARK ST ALAMEDA 94501 WALMART PHARMACY #10-2989 44009 OSGOOD RD FREMONT 94539 WALMART PHARMACY #10-5426 40580 ALBRAE ST FREMONT 94538 WALMART PHARMACY 10 2161 4501 ROSEWOOD DRIVE PLEASANTON 94588 WALMART PHARMACY NO 10 2648 1919 DAVIS STREET SAN LEANDRO 94577 WELLSPRING COMPOUNDING PHARMACY 2320 WOOLSEY ST. #105 BERKELEY 94705 WEST OAKLAND HEALTH CENTER PHARM 700 ADELINE ST OAKLAND 94607 53 Appendix E Kiosk Mock-Up 54 Kiosk Signage1 Drop-Slot Panel Kiosk Art 1 Household Hazardous Waste facilities do not accept illicit drugs. 55 Kiosk Signage Front Door Panel Kiosk Art 56 Kiosk Signage Side Panel Kiosk Art 57 Appendix F Media List The following is a representative list of key media outlets to help educate Residents about proper disposal of expired or Unwanted Medicine. The list includes local print, online, television, and radio outlets, as well as outlets specifically targeting the diverse demographic communities within the County. Print Outlets Coverage Area Website Alameda Sun Alameda County http://alamedasun.com/ Berkeley Daily Planet Berkeley http://berkeleydailyplanet.com Berkeley Voice Berkeley https://www.eastbaytimes.com/location/berkeley/ Berkeleyside Berkeley http://www.berkeleyside.com California Magazine Berkeley https://alumni.berkeley.edu/california-magazine Castro Valley Forum (Weekly newspaper) Alameda County http://castrovalleyforum.com/home.html Castro Valley News Alameda County https://castrovalleynewsgroup.com/category/castro- valley/ Castro Valley Times Castro Valley https://www.eastbaytimes.com/location/castro-valley/ Center for Investigative Reporting Berkeley Contra Costa Times Alameda County http://www.eastbaytimes.com/ Dublin Tri Valley Herald Dublin https://www.eastbaytimes.com/location/tri-valley/ E'ville Eye Community News Alameda County http://www.evilleeye.com/ Nichi Bei Times (Japanese/English) Alameda County http://www.EastBayExpress.com/ East Bay Express Oakland https://www.eastbayexpress.com East Bay Times Alameda County https://www.eastbaytimes.com East Bay Express Alameda County https://www.eastbayexpress.com Fremont Bulletin Alameda County http://www.mercurynews.com/fremont 58 Print Outlets Coverage Area Website Fremont Tribune Alameda County http://www.fremonttribune.com/ Hayward Daily Review (SEE Oakland Tribune) Alameda County http://haywardnews.ca/ The Independent Dublin, Livermore, Pleasanton http://www.independentnews.com Inter-City Express Oakland www.intercityexpress.news La Opinion (Spanish) Alameda County http://www.laopinion.com/ Oakland Local Oakland http://oaklandlocal.com/ Oakland Post Alameda County http://www.oaklandpost.org Oakland Tribune Alameda County https://www.eastbaytimes.com Pleasanton Weekly Alameda County https://www.pleasantonweekly.com San Francisco Chronicle Alameda County https://www.sfchronicle.com San Leandro Times Alameda County http://sanleandrotimes.com/home.html The Alamedan Alameda County http://thealamedan.org The Argus Alameda County https://www.eastbaytimes.com/location/fremont/ The Daily Californian (UC Berkeley) Alameda County http://www.dailycal.org The Montclarion Oakland http://themontclarion.org The Piedmont Post Piedmont http://www.piedmontportal.org/the-piedmont-post/ Tri-Valley Times Pleasanton https://www.eastbaytimes.com/location/tri-valley/ Tri-City Voice Alameda County http://www.tricityvoice.com/ Vision Hispana Oakland, Hayward http://www.visionhispanausa.com Your Town Monthly Alameda County http://yourtownmonthly.com 59 Television Outlets Network BAVC Public Access KDTV Univision KEMO Azteca America KGO ABC KNTV NBC KPIX CBS KQED PBS KRON Media General KSTS Telemundo KTVU FOX 60 Radio Outlets City/County/Coverage Area KALW FM 91.7 San Francisco KCBS AM 740 San Francisco KCSF (College app radio) San Francisco KGO AM 810 San Francisco KQED FM 88.5 San Francisco KSFO AM 560 San Francisco KUSF (College online radio) San Francisco KPFB FM 89.3 Berkeley KALX FM 90.7 Berkeley KNGY FM 92.7 Alameda KPFA FM 94.1 Berkeley KKIQ FM 101.7 Livermore KBLX FM 102.9 Berkeley KNEW AM 910 Oakland KKGN AM 960 Oakland KMKY AM 1310 Oakland KVTO AM 1400 Berkeley KPIG AM 1510 Piedmont KACR FM 96.1 Alameda KCRH FM 89.9 Hayward KPOO 89.5 San Francisco KSMC 89.5 Moraga KCSM 91.1 San Mateo 61 Radio Outlets City/County/Coverage Area KKDV 92.1 Walnut Creek KRZZ 93.3 San Francisco KYLD 94.9 San Francisco KBWF 95.7 San Francisco KOIT 96.5 San Francisco KLLC 97.3 San Francisco KISQ 98.1 San Francisco KSOL 98.9 San Francisco KMVQ 99.7 San Francisco KBRG 100.3 San Jose KVVZ 100.7 San Rafael KIOI 101.3 San Francisco KDFC 102.1 San Francisco KKSF 103.7 San Francisco KFOG 104.5 San Francisco KITS 105.3 San Francisco KVVF 105.7 Santa Clara KMEL 106.1 San Francisco KFRC 106.9 San Francisco KSTN 107.3 Stockton KSAN 107.7 San Mateo KSFO 560 AM San Francisco KEAR 610 AM San Francisco 62 Radio Outlets City/County/Coverage Area KSTE 650 AM Rancho Cordova KNBR 680 AM San Francisco KFIA 710 AM Carmichael KCBC 770 AM Riverbank KTRB 860 AM San Francisco KATD 990 AM Pittsburg KIQI 1010 AM San Francisco KTCT 1050 AM San Mateo KFAX 1100 AM San Francisco KHTK 1140 AM Sacramento KLOK 1170 AM San Jose KDYA 1190 AM Vallejo KNTS 1220 AM Palo Alto KSRO 1350 AM Santa Rosa KZSF 1370 AM San Jose KEST 1450 AM San Francisco KTOB 1490 AM Petaluma KFBK 1530 AM Sacramento KYCY 1550 AM San Francisco KLIV 1590 AM San Jose KDIA 1640 AM Vallejo KEBR 88.1 Sacramento KECG 88.1 El Cerrito 63 Radio Outlets City/County/Coverage Area KXPR 88.9 Sacramento KOHL 89.3 Fremont KREV 92.7 Alameda KSFN 1510 AM Piedmont 64 Appendix G MED-Project Request for Approval of Disposal Process for Host-Assisted Collection Kiosk Drop-Off Sites MED-PROJECT REQUEST FOR APPROVAL OF DISPOSAL PROCESS FOR HOST-ASSISTED COLLECTION KIOSK DROP-OFF SITES February 15, 2019 65 MED-PROJECT REQUEST FOR APPROVAL OF DISPOSAL PROCESS FOR HOST-ASSISTED COLLECTION KIOSK DROP-OFF SITES Pursuant to Alameda County Safe Drug Disposal Ordinance (“Ordinance”) § 6.53.060(A) and Alameda County Safe Drug Disposal Regulations (“Regulations”) § 17, MED-Project LLC (“MED-Project”) requests the Alameda County Department of Environmental Health’s (the “Department’s”) approval to use a municipal waste combustor for the disposal of materials collected at Host-Assisted Collection Kiosk Drop-Off Sites (as defined in the MED-Project Product Stewardship Plan (“Plan”) § III). As described below, exercising discretion to allow for the disposal of materials collected at Host-Assisted Collection Kiosk Drop-Off Sites would achieve the objectives of the Ordinance and Regulations and should be approved under Ordinance § 6.53.060(A) and Regulations § 17. I. THE PROCESS FOR THE DISPOSAL OF MATERIALS FROM HOST-ASSISTED COLLECTION KIOSK DROP-OFF SITES AT COVANTA LONG BEACH To provide effective and uninterrupted collection from Host-Assisted Collection Kiosk Drop-Off Sites, MED- Project has identified two vendors that it may use to provide and dispose of unwanted medicine. This request for approval concerns Covanta Environmental Solutions, LLC (“Covanta”). MED-Project is proposing that materials collected at Host-Assisted Collection Kiosk Drop-Off Sites be delivered by United Parcel Service, Inc. to the Covanta Environmental Solutions, LLC facility in Scottsdale, Arizona. See Plan § X. From there, the materials will be transported by Transchem Environmental, LLC to the Covanta Long Beach Renewable Energy1 facility in Long Beach, California (“Covanta Long Beach”)2 for destruction via incineration. Id. Two DEA witnesses from Covanta will monitor delivery from the reverse distribution vault to Covanta Long Beach. A DEA witness will then confirm the destruction of the collected materials in the tracking system and upload the DEA certificate of destruction. Covanta Long Beach is a municipal waste combustor. Covanta Long Beach is a waste-to-energy facility that processes up to 1,380 tons of municipal solid waste per day, generating up to 36 megawatts of electricity. Covanta Long Beach also has a Clean Air Act Title V permit, which establishes air emissions limits for particulate matter, carbon monoxide, sulfur dioxide, nitrogen oxides, lead, mercury, and fluorides, among other chemicals. To control air pollution, Covanta Long Beach employs semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a nitrogen oxide control system, a mercury control system, activated carbon filter units, and a continuous emissions monitoring system. II. STANDARD FOR DEPARTMENT TO APPROVE THE USE OF COVANTA LONG BEACH FOR THE DISPOSAL OF MATERIALS FROM HOST-ASSISTED COLLECTION KIOSK DROP-OFF SITES The Regulations allow the “Plan Liaison” (as defined in Regulations § 2) to request an “exception, exemption, or allowance from any requirement of the Ordinance or Regulations,” which the “Department shall have the discretion to grant or deny . . ..” Regulations § 17. Any disposal of unwanted medicine must comply with the overarching Ordinance disposal requirement that “[e]ach Product Stewardship Program must comply with all local, state, and federal laws and regulations applicable to its operations, including laws and regulations governing the disposal of medical waste and Controlled Substances.” Ordinance § 6.53.060(A); cf. Ordinance § 6.53.120(B) (“This Chapter shall be construed so as not to conflict with applicable federal or state laws, rules or regulations.”). 1 The Southeast Resource Recovery Facility is operating as Covanta Long Beach Renewable Energy. See Covanta, Covanta Long Beach, https://www.covanta.com/Our-Facilities/Covanta-Long-Beach (last visited Aug. 19, 2018). 2 Covanta Long Beach’s mailing address is 118 pier S Avenue, Long Beach, CA 90802. 66 III. THE USE OF COVANTA LONG BEACH TO DISPOSE OF MATERIALS FROM HOST- ASSISTED COLLECTION KIOSK DROP-OFF SITES SHOULD BE APPROVED The Department should approve the use of Covanta Long Beach for disposal of materials from Host-Assisted Collection Kiosk Drop-Off Sites under Ordinance § 6.53.060(A) and Regulations § 17 because disposal at Covanta Long Beach would comply with federal and state law, improve MED-Project unwanted medicine collection services for residents, and protect and preserve the environment and the public health, safety, and welfare of Alameda County residents. A. Disposal at Covanta Long Beach Complies with Federal and State Law. There are no other laws or requirements, outside of the Ordinance, that would require MED-Project to dispose of unwanted medicine collected from Host-Assisted Collection Kiosk Drop-Off Sites at a hazardous waste incinerator or medical waste incinerator or preclude MED-Project from disposing of these materials at a municipal waste combustor like Covanta Long Beach. Any unwanted medicine collected at Host-Assisted Collection Kiosk Drop- Off Sites under this Plan is considered “household waste” excluded from regulation as hazardous or medical waste. Therefore, disposal of unwanted medicine at Covanta Long Beach in accordance with DEA requirements complies with all applicable federal and state laws, regulations, and other legal requirements. In fact, municipal waste combustors like Covanta Long Beach are one of the disposal methods the United States Environmental Protection Agency directs law enforcement agencies to use for the destruction of collected pharmaceutical products. See United States Environmental Protection Agency, Management of Household Pharmaceuticals Collected by Law Enforcement During Take-Back Events and Programs at 2, 4 (Sept. 11, 2018). B. Disposal of Unwanted Medicine at Covanta Long Beach Improves MED-Project Services for Residents. MED-Project requests approval to use Covanta Long Beach to create redundancy in its unwanted medicine collection and disposal services. By adding Covanta as a Host-Assisted Collection Kiosk Drop-Off Site vendor and Covanta Long Beach as a disposal facility, MED-Project can protect against service interruptions. Should Covanta or MED-Project’s other vendor servicing Host-Assisted Collection Kiosk Drop-Off Sites, Stericycle Specialty Waste Solutions, Inc., experience an incident requiring it to temporarily suspend services, MED-Project can continue to rely on the other vendor to provide service for Alameda County residents. C. Disposal at Covanta Long Beach Would Protect and Preserve the Environment and the Public Health, Safety, and Welfare of Alameda County Residents. The Department should exercise its authority to approve the use of Covanta Long Beach for disposal of unwanted medicine from Host-Assisted Collection Kiosk Drop-Off Sites under Ordinance § 6.53.060(A) and Regulations § 17 because disposal at Covanta Long Beach would protect and preserve the environment and the public health, safety, and welfare of Alameda County residents in furtherance of the objectives of the Ordinance. Municipal waste combustors like Covanta Long Beach are subject to stringent environmental requirements, as well as worker health and safety standards like other incinerators. Covanta Long Beach is subject to a Clean Air Act Title V permit for air emissions, and the facility has extensive air pollution controls in place, including semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a nitrogen oxide control system, a mercury control system, activated carbon filter units, and a continuous emissions monitoring system. The permits and other requirements that apply to Covanta Long Beach provide for and promote the health, safety, and welfare of the general public. Accordingly, the Department should exercise its discretion under Regulations § 17 to approve Covanta Long Beach as a disposal site for materials collected at Host-Assisted Collection Kiosk Drop-Off Sites. 67 IV. CONCLUSION For the reasons described above, the Department should approve the disposal of unwanted medicine from Host- Assisted Collection Kiosk Drop-Off Sites as proposed by MED-Project under Ordinance § 6.53.060(A) and Regulations § 17. Please contact the Plan Liaison, identified below, with any questions about this request. Dr. Victoria Travis, PharmD, MS, MBA National Program Director MED-Project LLC 1800 M Street NW, Suite 400 S Washington, DC 20036 Phone: 1 (844) 677-6532 Fax: 1 (510) 686-8837 alamedacounty@med-project.org 68 Appendix H A. Stericycle Standard Mail-Back Package Description: Plastic envelope with return label and instructional flyer Package Size: Outer dimensions: 8.25” x 12” Inner dimensions: 7.375” x 10.375” MED-Project may choose to change its Vendor for Mail-Back Services at any time. Any proposed changes to Vendor will be submitted in writing to the Department and approved by the Department in writing prior to implementation of any change. 69 B. Covanta Standard Mail-Back Package MED-Project may choose to change its Vendor for Mail-Back Services at any time. Any proposed changes to Vendor will be submitted in writing to the Department and approved by the Department in writing prior to implementation of any change. 70 C. PureWay Inhaler Mail-Back Package Specifications Description: Inhaler Mail-Back Package including container with mail-back packaging, return label, and instructional flyer. Package Sizes: 2.5-gallon mail-back system Mail-back solutions are an example of complete, turnkey systems to provide for the safe return of inhaler waste through Carrier. MED-Project may choose to change its Vendor for Mail-Back Services at any time. Any proposed changes to Vendor will be submitted in writing to the Department and approved by the Department in writing prior to implementation of any change. 71 D. Stericycle Inhaler Mail-Back Package Description: Inhaler Mail-Back Package including container with mail-back packaging, return label, and instructional flyer. Package Sizes: Outer dimensions: 8.75”x 11.25”x 3” Mail-back solutions are an example of complete, turnkey systems to provide for the safe return of inhaler waste through Carrier. MED-Project may choose to change its Vendor for Mail-Back Services at any time. Any proposed changes to Vendor will be submitted in writing to the Department and approved by the Department in writing prior to implementation of any change. 72 Appendix I MED-Project Request for Approval of Standard Mail-Back Package Disposal Process MED-PROJECT REQUEST FOR APPROVAL OF STANDARD MAIL-BACK PACKAGE DISPOSAL PROCESS February 15, 2019 73 MED-PROJECT REQUEST FOR APPROVAL OF STANDARD MAIL-BACK PACKAGE DISPOSAL PROCESS Pursuant to Alameda County Safe Drug Disposal Ordinance (“Ordinance”) § 6.53.060(A) and Alameda County Safe Drug Disposal Regulations (“Regulations”) § 17, MED-Project LLC (“MED-Project”) requests the Alameda County Department of Environmental Health’s (the “Department’s”) approval to use permitted municipal waste combustors for the disposal of “Standard Mail-Back Packages” for unwanted medicine (as defined in the MED-Project Product Stewardship Plan (“Plan”) § III). As described below, exercising discretion to allow for the disposal of Standard Mail-Back Packages at municipal waste combustors would achieve the objectives of the Ordinance and Regulations and should be approved under Ordinance § 6.53.060(A) and Regulations § 17. I. THE PROCESS FOR THE DISPOSAL OF STANDARD MAIL-BACK PACKAGES To provide effective and uninterrupted “Standard Mail-Back Services” (as defined in Plan § III), MED-Project has identified two vendors that it may use to provide and dispose of Standard Mail-Back Packages. This request for approval concerns Covanta Environmental Solutions, LLC (“Covanta”). A. The Covanta Process Standard Mail-Back Packages provided by Covanta would be pre-addressed and pre-paid for delivery to the Covanta Manheim, Pennsylvania United States Drug Enforcement Agency (“DEA”) registered collector and reverse distributor facility (“Manheim Facility”). From the Manheim Facility, the mail-back packages are transported by Doncin Transport, Inc. to one of two Covanta facilities—the Covanta York Renewable Energy, LLC facility in York, Pennsylvania (“Covanta York”)1 and the Covanta Lancaster, Inc. facility in Lancaster, Pennsylvania (“Covanta Lancaster”)2 (together, the “Covanta Facilities”)—for destruction via incineration. See Plan § X. The Covanta Facilities will scan the unique identifier on each Standard Mail-Back Package to record receipt of the package before incinerating it and will confirm the materials have been properly incinerated. a. Covanta York Covanta York is a permitted large municipal waste combustor. As an “energy-from-waste” facility, Covanta York uses solid waste, like Standard Mail-Back Packages, to generate electricity.3 The facility processes over 1,300 tons of solid waste per day, generating up to 40 megawatts of electricity, enough to power over 20,000 homes, according to its website. To control air pollution, Covanta York employs a niro spray drying atomizer, a Western Pacific filter baghouse, and Norit Americas carbon injection. Covanta York also operates under a Title V Clean Air Act permit4 and a solid waste permit.5 Additionally, Covanta York has been designated as a Voluntary Protection Program (“VPP”) Star facility by the U.S. Occupational Safety and Health Administration (“OSHA”), recognizing the facility’s employer’s and employees’ exemplary achievement in the prevention and control of occupational safety and health hazards. Covanta York has also been awarded ISO-140001 certification for the facility’s environmental management system. 1 Covanta York’s mailing address is 2651 Blackbridge Road, York, PA 17406. 2 Covanta Lancaster’s mailing address is 1911 River Road, Bainbridge, PA 17502. 3 See Covanta, Covanta York, https://www.covanta.com/Our-Facilities/Covanta-York. 4 See Title V Operating Permit # 67-05006, http://files.dep.state.pa.us/Air/AirQuality/AQPortalFiles/Permits/PermitDocuments/1141655[67- 05006]_Issued_v1.pdf. 5 See Solid Waste Permit # 400561 PaDEP, https://www.ahs.dep.pa.gov/eFACTSWeb/searchResults_singleFacility.aspx?FacilityID=471124. 74 b. Covanta Lancaster Covanta Lancaster is also a permitted large municipal waste combustor. Covanta Lancaster is an “energy-from- waste” facility that incinerates waste and generates 35.7 megawatts per day from a condensing steam turbine that provides energy to GPU Energy.6 Covanta Lancaster employs semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a furnace dry-lime injection system, a nitrogen oxide control system, a mercury control system, and a continuous emissions monitoring system. Covanta Lancaster also operates under a Title V Clean Air Act permit7 and a solid waste permit.8 Covanta Lancaster is a “zero discharge” facility, meaning that the wastewater generated on-site is treated and reused in the waste management process, according to the facility’s website. Covanta Lancaster has also been designated as a VPP Star facility by OSHA. II. STANDARD FOR DEPARTMENT TO APPROVE THE USE OF THE PROPOSED INCINERATORS FOR THE DISPOSAL OF STANDARD MAIL-BACK PACKAGES The Regulations allow the “Plan Liaison” (as defined in Regulations § 2) to request an “exception, exemption, or allowance from any requirement of the Ordinance or Regulations,” which the “Department shall have the discretion to grant or deny . . ..” Regulations § 17. Any disposal of Standard Mail-Back Packages must comply with the overarching Ordinance disposal requirement that “[e]ach Product Stewardship Program must comply with all local, state, and federal laws and regulations applicable to its operations, including laws and regulations governing the disposal of medical waste and Controlled Substances.” Ordinance § 6.53.060(A); cf. Ordinance § 6.53.120(B) (“This Chapter shall be construed so as not to conflict with applicable federal or state laws, rules or regulations.”). III. THE USE OF THE PROPOSED INCINERATORS TO DISPOSE OF STANDARD MAIL- BACK PACKAGES SHOULD BE APPROVED The Department should approve the use of the proposed incinerators for disposal of Standard Mail-Back Packages under Ordinance § 6.53.060(A) and Regulations § 17 because disposal at the proposed incinerators would comply with federal and state law, improve MED-Project unwanted medicine collection services for residents, and protect and preserve the environment and the public health, safety, and welfare of Alameda County residents. A. Disposal at the Covanta Facilities Complies with Federal and State Law There are no other laws or requirements, outside of the Ordinance, that would require MED-Project to dispose of Standard Mail-Back Packages at a hazardous waste incinerator or medical waste incinerator or preclude MED- Project from disposing of these materials at a municipal waste combustor like the Covanta Facilities. Any unwanted medicines collected via Standard Mail-Back Packages under this Plan are considered “household waste” excluded from regulation as hazardous or medical waste. Therefore, disposal of Standard Mail-Back Packages at the Covanta Facilities in accordance with DEA requirements complies with all applicable federal and state laws, regulations, and other legal requirements. In fact, municipal waste combustors like the Covanta Facilities are one of the disposal methods the United States Environmental Protection Agency directs law enforcement agencies to use for the destruction of collected pharmaceutical products. See United States Environmental Protection Agency, Management of Household Pharmaceuticals Collected by Law Enforcement During Take-Back Events and Programs at 2, 4 (Sept. 11, 2018). 6 See Covanta, Covanta Lancaster, https://www.covanta.com/Our-Facilities/Covanta-Lancaster. 7 See Title V Operating Permit # 36-05013, http://files.dep.state.pa.us/Air/AirQuality/AQPortalFiles/Permits/PermitDocuments/1130890[36- 05013]_Issued_v1.pdf. 8 See Solid Waste Permit # 400592 PaDEP, https://www.ahs.dep.pa.gov/eFACTSWeb/searchResults_singleFacility.aspx?FacilityID=255039. 75 B. Disposal of Standard Mail-Back Packages at the Covanta Facilities Improves MED-Project Services for Residents MED-Project requests approval to use the proposed incinerators to create redundancy in its Standard Mail-Back Services. By adding Covanta as a Standard Mail-Back Services vendor, MED-Project can protect against Standard Mail-Back Service interruptions. Should Covanta or MED-Project’s other vendor for Standard Mail-Back Services, Stericycle Specialty Waste Solutions, Inc., experience an incident requiring it to temporarily suspend Standard Mail- Back Services for any reason, MED-Project can continue to rely on the other vendor to provide service for Alameda County residents. C. Disposal at the Proposed Facilities would Protect and Preserve the Environment and the Public Health, Safety, and Welfare of Alameda County Residents. The Department should exercise its authority to approve the use of the proposed incinerators for disposal of Standard Mail-Back Packages under Ordinance § 6.53.060(A) and Regulations § 17 because disposal at the proposed incinerators would protect and preserve the environment and the public health, safety, and welfare of Alameda County residents in furtherance of the objectives of the Ordinance. Covanta York has extensive pollution control technologies in place, including its use of a niro spray drying atomizer, a Western Pacific filter baghouse, and Norit Americas carbon injection. It has also been recognized for its workplace safety achievements, as evidenced by its status as a VPP Star facility. Covanta Lancaster has extensive pollution control technologies in place, including semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a nitrogen oxide control system, a mercury control system, and a continuous emissions monitoring system. It has also been recognized for its workplace safety achievements, as evidenced by its status as a VPP Star facility. The use of Covanta York and Covanta Lancaster would protect and preserve the environment and the public health, safety, and welfare of Alameda County residents in furtherance of the objectives of the Ordinance. IV. CONCLUSION Accordingly, the Department should approve the disposal of Standard Mail-Back Packages via incineration at Covanta York and Covanta Lancaster as proposed by MED-Project under Ordinance § 6.53.060(A) and Regulations § 17. Please contact the Plan Liaison, identified below, with any questions about this request. Dr. Victoria Travis, PharmD, MS, MBA National Program Director MED-Project LLC 1800 M Street NW, Suite 400 S Washington, DC 20036 Phone: 1 (844) 677-6532 Fax: 1 (510) 686-8837 alamedacounty@med-project.org 76 Appendix J MED-Project Request for Approval of Inhaler Mail-Back Package Disposal Process MED-PROJECT REQUEST FOR APPROVAL OF INHALER MAIL-BACK PACKAGE DISPOSAL PROCESS February 15, 2019 77 MED-PROJECT REQUEST FOR APPROVAL OF INHALER MAIL-BACK PACKAGE DISPOSAL PROCESS Pursuant to Alameda County Safe Drug Disposal Ordinance (“Ordinance”) § 6.53.060(A) and Alameda County Safe Drug Disposal Regulations (“Regulations”) § 17, MED-Project LLC (“MED-Project”) requests the Alameda County Department of Environmental Health’s (the “Department’s”) approval to use permitted municipal waste combustors for the disposal of “Inhaler Mail-Back Packages” (as defined in the MED-Project Product Stewardship Plan (“Plan”) § III). As described below, exercising discretion to allow for the disposal of Inhaler Mail-Back Packages at a permitted municipal waste combustor would achieve the objectives of the Ordinance and Regulations and should be approved under Ordinance § 6.53.060(A) and Regulations § 17. I. THE PROCESS FOR THE DISPOSAL OF INHALER MAIL-BACK PACKAGES To provide effective and uninterrupted “Inhaler Mail-Back Services” (as defined in Plan § III), MED-Project has identified two vendors that it may use to provide and dispose of Inhaler Mail-Back Packages. This request concerns PureWay Compliance, Inc. (“PureWay”). The Inhaler Mail-Back Packages provided by PureWay will be pre-addressed and pre-paid for delivery to the Daniels Sharpsmart, Inc. facility in Fresno, California (the “Daniels Facility”) for transport to one of two incinerators for disposal: the Covanta Huntsville, Inc. facility (the “Covanta Huntsville Facility”)1 or the Covanta Marion, Inc. facility (the “Covanta Marion Facility”).2 See Plan § X. The Daniels Facility will scan the unique identifier on each Inhaler Mail-Back Package to record receipt of the package before sending it for incineration to one of these two facilities. These facilities will receive and dispose of the Inhaler Mail-Back Packages and provide confirmation that the materials have been properly incinerated and disposed of. A. Covanta Huntsville Facility The Covanta Huntsville Facility is a permitted large municipal waste combustor. The furnaces at the Covanta Huntsville Facility are operated at temperatures exceeding 1800 degrees Fahrenheit.3 As a “waste-to-energy” facility, the Covanta Huntsville Facility uses municipal solid waste, like Inhaler Mail-Back Packages, to generate steam used for the U.S. Army’s nearby Redstone Arsenal’s heating and air conditioning needs.4 To control air pollution, the Covanta Huntsville Facility employs semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a nitrogen oxide control system, a mercury control system, and a continuous emissions monitoring system. Additionally, the Covanta Huntsville Facility has been designated as a Voluntary Protection Program (“VPP”) Star facility by the U.S. Occupational Safety and Health Administration (“OSHA”), recognizing the facility’s employer’s and employees’ exemplary achievement in the prevention and control of occupational safety and health hazards.5 1 Covanta Huntsville’s mailing address is 5251 Triana Blvd SW, Huntsville, AL 35805. 2 Covanta Marion’s mailing address is 4850 Brooklake Road, NE, Brooks, OR 97305. 3 See Solid Waste Disposal Authority of the City of Huntsville, Waste to Energy, http://swdahsv.org/waste-to-energy/. 4 See Covanta, Covanta Huntsville, https://www.covanta.com/Our-Facilities/Covanta-Huntsville. 5 Id.; U.S. Occupational Health and Safety Administration, All About VPP, https://www.osha.gov/dcsp/vpp/all_about_vpp.html. 78 B. Covanta Marion Facility The Covanta Marion Facility is also a permitted large municipal waste combustor. The Covanta Marion Facility is a “waste-to-energy” facility that incinerates waste and generates 13.1 megawatts per day from a condensing steam turbine generator.6 Like the Covanta Huntsville Facility, the Covanta Marion Facility employs semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a nitrogen oxide control system, a mercury control system, and a continuous emissions monitoring system.7 The Covanta Marion Facility is a member of the Safety and Health Achievement Recognition Program (“SHARP”), Oregon’s safety and health recognition program.8 The Covanta Marion Facility has also been designated as a VPP Star facility by OSHA.9 II. STANDARDS FOR THE DEPARTMENT TO APPROVE THE USE OF THE PROPOSED INCINERATORS FOR THE DISPOSAL OF INHALER MAIL-BACK PACKAGES The Regulations allow the “Plan Liaison” (as defined in Regulations § 2) to request an “exception, exemption, or allowance from any requirement of the Ordinance or Regulations,” which the “Department shall have the discretion to grant or deny . . ..” Regulations § 17. Any disposal of Mail-Back Packages must comply with the overarching Ordinance disposal requirement that “[e]ach Product Stewardship Program must comply with all local, state, and federal laws and regulations applicable to its operations, including laws and regulations governing the disposal of medical waste and Controlled Substances.” Ordinance § 6.53.060(A); cf. Ordinance § 6.53.120(B) (“This Chapter shall be construed so as not to conflict with applicable federal or state laws, rules or regulations.”). III. THE USE OF THE PROPOSED INCINERATORS TO DISPOSE OF INHALER MAIL-BACK PACKAGES SHOULD BE APPROVED The Department should approve the use of the Covanta Huntsville Facility and Covanta Marion Facility for disposal of Inhaler Mail-Back Packages under Ordinance § 6.53.060(A) and Regulations § 17 because disposal at these facilities would comply with federal and state law, improve MED-Project Inhaler Mail-Back Services for residents, and protect and preserve the environment and the public health, safety, and welfare of Alameda County residents. A. Disposal at the Covanta Huntsville Facility and Covanta Marion Facility Complies with Federal and State Law. There are no other laws or requirements, outside of these Regulations, that would require MED-Project to dispose of Inhaler Mail-Back Packages at a hazardous waste incinerator or medical waste incinerator or preclude MED-Project from disposing of these materials at a municipal waste combustor like the Covanta Huntsville Facility or Covanta Marion Facility. Any Inhaler Mail-Back Packages collected under this Plan are considered “household waste” excluded from regulation as medical or hazardous waste. Therefore, disposal of unwanted medicines at these facilities complies with all applicable federal and state laws, regulations, and other legal requirements. In fact, municipal waste combustors like the Covanta Huntsville Facility and Covanta Marion Facility are one of the disposal methods the United States Environmental Protection Agency directs law enforcement agencies to use for the destruction of collected pharmaceutical products. See United States Environmental Protection Agency, Management of Household Pharmaceuticals Collected by Law Enforcement During Take-Back Events and Programs at 2, 4 (Sept. 11, 2018). 6 See Covanta, Covanta Marion, https://www.covanta.com/Our-Facilities/Covanta-Marion. 7 Id. 8 Id. 9 Id.; U.S. Occupational Health and Safety Administration, All About VPP, https://www.osha.gov/dcsp/vpp/all_about_vpp.html. 79 B. Disposal of Inhaler Mail-Back Packages at the Covanta Huntsville Facility and Covanta Marion Facility Improves MED-Project Inhaler Mail-Back Services for Residents. MED-Project requests approval to use the Covanta Huntsville Facility and Covanta Marion Facility to create redundancy in its Inhaler Mail-Back Services. By adding PureWay as an Inhaler Mail-Back Services vendor and the Covanta Huntsville Facility and Covanta Marion Facility as disposal facilities, MED-Project can protect against service interruptions. Should PureWay or MED-Project’s other Inhaler Mail-Back Services vendor, Stericycle Specialty Waste Solutions, Inc., experience an incident requiring it to temporarily suspend services for any reason, MED-Project can continue to rely on the other vendor to provide Inhaler Mail-Back Services for Alameda County residents. C. Disposal at the Proposed Facilities Would Protect and Preserve the Environment and the Public Health, Safety, and Welfare of Alameda County Residents. The Covanta Huntsville Facility and the Covanta Marion Facility have extensive pollution control technologies in place, including semi-dry flue gas scrubbers injecting lime, fabric filter baghouses, a nitrogen oxide control system, a mercury control system, and a continuous emissions monitoring system. They have also been recognized for their workplace safety achievements, as evidenced by their status as VPP Star facilities. The use of these facilities would protect public health and prevent unwanted medicine from being disposed of in a manner that can adversely affect the environment in furtherance of the objectives of the Ordinance. IV. CONCLUSION Accordingly, the Department should approve the disposal of Inhaler Mail-Back Packages via incineration at the Covanta Huntsville Facility and the Covanta Marion Facility as proposed by MED-Project under Ordinance § 6.53.060(A) and Regulations § 17. Please contact the Plan Liaison, identified below, with any questions about this request. Dr. Victoria Travis, PharmD, MS, MBA National Program Director MED-Project LLC 1800 M Street NW, Suite 400 S Washington, DC 20036 Phone: 1 (844) 677-6532 Fax: 1 (510) 686-8837 alamedacounty@med-project.org 80 Appendix K Stericycle, Inc., Indianapolis Facility Penalty Record Date Type Summary Violation Detail Return to Compliance Corrective Action 6/15/2017 RCRA Inventory weight discrepancy Discrepancy on the hazardous waste inventory log 6/15/2017 Violation corrected during audit, no further action required 3/29/2017 RCRA Inventory weight discrepancy Discrepancy on the hazardous waste inventory log 3/29/2017 Violation corrected during audit, no further action required 3/29/2017 RCRA Hazardous waste labeling Containers missing date 3/29/2017 Violation corrected during audit, no further action required 7/25/2016 RCRA Inventory dates Inventory dates and physical dates on containers did not match 10/25/2016 Responded to Indiana Department of Environmental Management (“IDEM”) with corrective action plan; issue closed with Return to Compliance Letter 7/17/2015 RCRA Hazardous waste labeling Unlabeled universal waste pallets 11/17/2015 Responded to IDEM with corrective action plan; issue closed with Return to Compliance Letter 7/17/2015 RCRA Contingency Plan Contingency Plan list of emergency coordinators not updated with current contact information 11/17/2015 Responded to IDEM with corrective action plan; issue closed with Return to Compliance Letter 81 Date Type Summary Violation Detail Return to Compliance Corrective Action 7/31/2014 RCRA Inventory weight discrepancy Discrepancies regarding the quantity (weight) of waste stored in permitted areas compared to the weights listed on the physical containers 9/8/2014 Responded to IDEM with corrective action plan; issue closed with Return to Compliance Letter 6/5/2014 Air Annual report not submitted Did not submit Annual Compliance Certification for period covering 1/1/13 to 12/31/13 6/9/2014 Report submitted to IDEM; issue closed with Return to Compliance Letter 3/26/2014 RCRA Satellite Accumulation violation Two containers exceeded the 3- day limit for moving satellite accumulation area to the container storage area 6/17/2014 Responded to IDEM with corrective action plan; issue closed with Return to Compliance Letter 3/26/2014 RCRA Inventory weight discrepancy Discrepancies regarding the quantity (weight) of waste stored in permitted areas compared to the weights listed on the physical containers 6/17/2014 Responded to IDEM with corrective action plan; issue closed with Return to Compliance Letter 3/26/2014 RCRA Container storage One container of hazardous waste located outside of the permitted area 6/17/2014 Responded to IDEM with corrective action plan; issue closed with Return to Compliance Letter 82 Date Type Summary Violation Detail Return to Compliance Corrective Action 6/28/2013 RCRA Satellite Accumulation/W aste Accumulation Labeling; Inventory Log discrepancy Missing satellite accumulation and UW label; Missing Accumulation Date and Waste Type; Discrepancy on container storage locations 10/16/2013 Responded to IDEM with corrective action plan; issue closed with Return to Compliance Letter 83 Veolia – Port Arthur Penalty Record Inspectio n Date Type of inspecti on Name of inspector and Regulatory Agency Alleged Violations VEOLIA Responses and/or Corrective Actions Taken 3/9/2017 Clean Air Act (“CAA”) Texas Commissi on on Environme ntal Quality (“TCEQ”) 1) Failure to maintain the Carbon Monoxide emission rate of 17.10 pounds per hour at the incinerator. 2) Failure to maintain Carbon Monoxide emissions of 100 parts per million by volume (ppmv) at the incinerator. 3) Failure to maintain incinerator minimum combustion temperatures. 4) Failure to maintain Arsenic and Chromium emission rates at the Incinerator. 5) Failure to maintain combined Cadmium-Lead and combined Arsenic-Beryllium-Chromium emissions at the Incinerator. 6) Failure to maintain the Carbon Monoxide emission rate of 17.10 pounds per hour during start-up at the Incinerator. 4/18/2017: Received NOV. 5/27/2017: Submitted Corrective Action Plan. 9/29/2017: Received a letter from the TCEQ stating adequate compliance documentation was received and no further action required. 5/16/2016 RCRA TCEQ 1) Failure to maintain hazardous waste tanks inspection records. 2) Failure to maintain a current NOR status of INACTIVE for hazardous waste tanks inspection records. 3) Failure to include on the emergency equipment list, One Self Contained Breathing Apparatus located at the onsite Response Office. 4) Failure to have legible posted signs with the legend Danger- Unauthorized Personnel Keep Out. 5) Failure to have adequate security to prevent unknowing site entry. 7/26/2016: Received NOV. 8/25/2016: Submitted Corrective Action Response. 3/1/2017: Received a letter from the TCEQ stating no further action required. 84 Inspectio n Date Type of inspecti on Name of inspector and Regulatory Agency Alleged Violations VEOLIA Responses and/or Corrective Actions Taken 1/26/2016 CAA Title V/New Source Review (“NSR”) Air TCEQ 1) Failure to maintain the Carbon Monoxide emission rate of 17.10 pounds per hour at the Incinerator. 2) Failure to maintain Carbon Monoxide emissions of 100 ppmv at the Incinerator. 3) Failure to maintain Incinerator minimum combustion temperatures. 4) Failure to maintain Arsenic, Beryllium, Cadmium, Chromium and Nickel emission rates at the Incinerator. 5) Failure to maintain combined Cadmium-Lead and combined Arsenic-Beryllium-Chromium emissions at the Incinerator. 6) Failure to prevent visible emissions at Tank T102. 7) Failure to make a first attempt at repair no later than 5 days after a leak is detected and failed to repair a leak no later than 15 days after a leak is detected. 4/27/2016: Received NOV from the TCEQ 6/3/2016: Submitted a response to the TCEQ. 9/20/2016: Received a letter from the TCEQ stating no further action required. 4/22/201 5 Texas Pollutant Dischar ge Eliminati on System (“TPDES ”) TCEQ 1) Failure to collect ammonia- nitrogen sample at the frequency specified in the Water Quality Discharge Permit for Outfall 001. 2) Failure to comply with test procedures specified in 30 TAC 319.11-319.12. 3) Failure to properly calculate the daily average for E. coli. 4) Failure to correctly report effluent data on the discharge monitoring report. 5/20/2015: Submitted a response to TCEQ 6/10/2015: Received a letter from the TCEQ stating no further action is required. 1/30/2015 Drinking Water TCEQ 1) Received NOV for failure to Provide or Report Public Notice. 2/20/2015: Submitted a response to TCEQ. 12/31/2015: No further correspondence received. 85 Inspectio n Date Type of inspecti on Name of inspector and Regulatory Agency Alleged Violations VEOLIA Responses and/or Corrective Actions Taken 1/16/2015 Drinking Water TCEQ 1) Failure to have an accurate and up to date plant operations manual. 2) Failure to inspect the interior of the 5,000-gallon pressure tank at least once every 5 years. 3) Failure to notify TCEQ prior to making any significant change or addition to the system's production, treatment, storage, pressure maintenance, or distribution facilities. 4) Failure to record the amount of chemicals used at least once a week. 5/29/2015: Submitted a response to TCEQ 7/30/2015: Received a request from the TCEQ for additional information. 11/3/2015: Submitted a response to TCEQ 12/30/2015: Received a letter from the TCEQ stating the drinking water project was approved. 1/6/2015 Air TCEQ 1) Failure to maintain the Carbon Monoxide emission rate at the Incinerator for the period of April 4, 2014 through August 18, 2014. 3/6/2015: Submitted a response to the TCEQ. 6/24/2015: Received a letter from TCEQ stating no further action is required. 11/3/2014 Drinking Water TCEQ Received an NOV for failure to submit Disinfectant Level Quarterly Operating Report. 9/26/201 4 RCRA TCEQ 1) Failure to document inspector's full name on daily inspection logs. 2) Failure to include a notation of the observations made during daily & weekly inspections 10/22/2014: Submitted Response to TCEQ. 2/9/2015: Received documentation stating no further action is required. 86 Inspectio n Date Type of inspecti on Name of inspector and Regulatory Agency Alleged Violations VEOLIA Responses and/or Corrective Actions Taken 2/20/201 3 CAA TCEQ 1) Failure to maintain a minimum power of 15 Kilovolt Amps to the Wet Electrostatic Precipitator (EPN INCINSTK). 2) Failure to conduct the 4th quarter Cylinder Gas Audits on the Hydrogen Chloride and Sulfur Dioxide CWMS. 3) Failure to maintain carbon monoxide emission rate at the Incinerator (EPN INCINSTK). 5/24/2013: Submitted Response to TCEQ for Alleged Violations 1. and 2. 6/21/2013: Received letter from the TCEQ stating no further action is required for Alleged Violations 1. and 2. 5/2/2013: Received Notice of Enforcement for Alleged Violation 3. 9/12/2013: Received Revised Proposed Agreed Order Assessing Penalty 9/16/2013: Submitted Payment of Penalty 2/20/2014: Received Final Agreed Order 3/25/2014: Submitted written certification and documents to demonstrate compliance. 8/22/2014: Received Notice of Compliance with Agreed Order 87 Heritage Thermal Services – Ohio Penalty Record Type of Action Date Address Regulatory Body/Agency Description of Alleged Violation Fine Amount Final Disposition Notice of violation (“NOV”) 5/26/17 Division of Air Pollution Control (“DAPC”) Heritage Thermal Services (“HTS”) exceeded total hydrocarbons 1-hr rolling average on March 25, 2017 (Title V). NA Closed – Ohio EPA (“OEPA”) issued resolution of violation letter on 7/11/17. NOV 2/12/16 OSHA Failure to ensure employee was wearing proper personal protective equipment (“PPE”). $27,720 Closed – HTS settled this matter on October 14, 2016. NOV 1/21/16 DAPC HTS exceeded NOx 3hr block average on June 28, 2015 (Title V). NA Closed - NOV resolved in letter dated 02/25/16; HTS responded with action plan in a letter dated February 5, 2016. Director’s Final Findings & Orders 4/2/2015 1250 Saint George Street East Liverpool, Ohio, 43920 OEPA, DAPC and Ohio Division of Materials and Waste Management (“DMWM”) NOVs issued to HTS due to the 7/13/13 Incident: Dust Nuisance (DAPC) Unlawful disposal of hazardous waste and improper maintenance and operation of equipment (DMWM) $34,000 HTS is in discussions with OEPA Finding of Violation 3/25/2015 1250 Saint George Street East Liverpool, Ohio, 43920 US EPA HTS exceeded Maximum Achievable Control Technology standard and Title V Operating Parameter Limits on several occasions. TBD HTS is in discussions with US EPA 88 Type of Action Date Address Regulatory Body/Agency Description of Alleged Violation Fine Amount Final Disposition NOV 9/16/2014 1250 Saint George Street East Liverpool, Ohio, 43920 DMWM Violation of Ohio Administrative Code (“OAC”) 3745-55- 75(b) Bulk waste container stored outside of secondary containment. NA Closed – Return to compliance (“RTC”) received in a letter dated December 8, 2014. September 16, 2014 letter acknowledged that issue had been corrected on date of inspection. NOV 9/16/2014 1250 Saint George Street East Liverpool, Ohio, 43920 DMWM Violation of OAC 3745-54-15(c) Immediate action had not been taken to prevent further incident following discovery of equipment damage. NA Closed – RTC received in a letter dated December 8, 2014, September 16, 2014 letter acknowledged that issue had been corrected on date of inspection. NOV 9/16/2014 1250 Saint George Street East Liverpool, Ohio, 43920 DMWM Violation of Permit Condition C.6(c) Spills not cleaned up in a timely manner. NA Closed – RTC received in a letter dated December 8, 2014, September 16, 2014 letter acknowledged that issue had been corrected on date of inspection. 89 Type of Action Date Address Regulatory Body/Agency Description of Alleged Violation Fine Amount Final Disposition NOV 10/2/2013 1250 Saint George Street East Liverpool, Ohio, 43920 DMWM Ash release on 7/13/13 was an unlawful Disposal of Hazardous Waste. Failure of proper Operation and Maintenance of equipment/facility NA HTS responded in a letter dated October 21, 2013. HTS met with OEPA on 9/22/14 to provide update. HTS provided written update and request for RTC in letter dated 10/17/14. HTS 2nd request for RTC in letter dated 12/12/14. HTS 3rd request for RTC in letter dated 2/3/2015. HTS has completed requirements for RTC and is actively pushing OEPA for RTC. 90 Type of Action Date Address Regulatory Body/Agency Description of Alleged Violation Fine Amount Final Disposition NOV 8/5/13 1250 Saint George Street East Liverpool, Ohio, 43920 DAPC Ash release determined to be a public nuisance in violation of OAC 3745-15-07 NA HTS responded in a letter dated August 22, 2013. HTS met with OEPA on 9/22/14 to provide update. HTS provided written update and request for RTC in letter dated 10/17/14. HTS 2nd request for RTC in letter dated 12/12/14. HTS 3rd request for RTC in letter dated 2/3/2015. HTS has completed requirements of RTC and is actively pushing OEPA for RTC. NOV 6/21/2013 1250 Saint George Street East Liverpool, Ohio, 43920 OSHA Violation of various standards – decontamination, improper storage of water reactives, not identifying hazards. $11,802 Closed – HTS settled this matter on 8/30/13. HTS and OSHA met for informal conference on 7/16/13. Agreement reached. Penalty reduced to $11,802. 91 Clean Harbors Aragonite Enforcement Summary Fact Sheet Clean Harbors Aragonite is subject to regulatory inspections by multiple agencies. While our goal is 100% compliance with all permits and regulatory requirements, inspections can result in alleged violations. This document is a summary from those inspections. Although the company does not necessarily concur with these findings, consistent with the company’s standard policy it has agreed to take all steps necessary to comply with the orders and to take such other corrective measures so as to ensure that the facility is in full compliance with its federal and state operating permits. In 2015 the facility resolved a notice of violation with USDEA. Alleged violations are listed below followed by the facility response in bold italicized text. 1. Failure to maintain a current license required by the state of Utah. A former compliance manager did not renew one of two state licenses. This was discovered during an internal audit and self- reported to both Utah and DEA. The facility voluntarily discontinued acceptance of controlled substances until the permit was obtained. 2. Failure to maintain separate biennial reports for Schedule I/II and III/IV/V controlled substances. The facility had zero inventory and reported that on one form. We disagreed with this allegation. If there was any inventory to report it would have been done on separate forms as required by the regulations. 3. Failure to maintain complete and accurate records. Information was contained on Form 41’s as required by regulation but would not fit in the column DEA considered appropriate. The facility began to use revised DEA form 41’s (that includes more space) to address the issue. This was resolved by a consent order that included a $63,000 penalty. In 2015 the facility resolved a notice of violation with Utah Board of Pharmacy for the same issue as #1 above. This was resolved by an administrative order that included a $20,000 penalty. In 2014 the facility resolved a notice of violation with USDEA. Alleged violations are listed below followed by the facility response in bold italicized text. 1. Failure to complete an accurate biennial inventory. The facility had zero inventory and reported that on a Clean Harbors letterhead. We disagreed with this violation. If there was any inventory to report it would have been done on forms as required by the regulations. 2. Failure to document the number of items received and the date items were received on a copy 3 of DEA form 222. This information was documented on a transfer form but not copied to a form 222. Facility personnel were retrained to address the issue. 3. Failure to execute a form 222 to transfer substances to another registered entity. A shipment count did not match and was rejected back to the generator. The facility did not include rejection using a form 222. Facility personnel were retrained to address the issue. 4. Failure to report the required documents in ARCOS in a complete and accurate manner. We disagreed with this violation. All reports were submitted to ARCOS. There were several errors not yet corrected at the time of the inspection. All errors were subsequently corrected. 92 This was resolved by a consent order that included a $190,000 penalty. In 2013 the facility resolved a notice of violation with UDEQ. This pertains to an annual RCRA inspection conducted in 2012. Alleged violations are listed below followed by the facility response in bold italicized text. 1. The facility self-reported a permit condition to record times each backup carbon adsorber is used was not followed. During an internal audit it was discovered a PLC that records backup carbon usage was rounding minutes incorrectly and slightly underreported usage. The programming was corrected. 2. The facility self-reported that a water reactive labpack in excess of four liters was accepted and incinerated, in violation of permit conditions. The material is acceptable but not in excess of four liters per container. The person responsible for the mistake was disciplined. 3. UDEQ alledged that weekly emergency shower and eyewash inspections were not noted in inspection tags. We disagreed with this violation. Inspections were performed and documented on an inspection log. 4. UDEQ alleged that a leaking roof repair was not completed within 72 hours as required by permit. We disagreed with this violation. During a January storm, ice accumulated on a roof over Building E-2. Once it warmed above freezing a small leak was discovered. Due to the dangers of roofing contractors on frozen roofs, this was not repaired until May 5. UDEQ alleged the facility did not report a fire as required by the permit. We disagreed with this violation. Heat tracing under pipe insulation shorted arced and melted wire insulation. There was not a fire and as such was not reportable. 6. UDEQ alleged that a RCRA air subpart BB/CC database and associated drawings were not kept updated. The database was accurate but drawings were not current. 7. UDEA alleged that an incoming container tested positive for oxidizers and that container should have been reclassified as a DOT oxidizer. We disagreed with this violation. The container held mixed acids, some of which do test positive for oxidizers. This was not an oxidizer per DOT standards. 8. The facility self-reported that an inbound trailer was not offloaded within 10 days as required by permit. No comment. This was self-reported. This was resolved by a consent order that included a $31,155 penalty. In 2012 the facility resolved a notice of violation with UDEQ. This pertains to an annual RCRA inspection conducted in 2011. Alleged violations are listed below followed by the facility response in bold italicized text. 1. UDEQ alleged there was a calibration problem with the oxygen analyzer in the hydrocarbon vent system. We disagreed with this violation. The facility inspection program found and corrected the problem prior to the inspection. This was corrected by installing a condensation trap and filter prior to the analyzer. 2. The facility self-reported to UDEQ that the direct burn flow meter was incorrectly calibrated. This was immediately corrected when discovered. 3. UDEQ alleged the facility did not properly describe a waste being accepted on the waste receiving report. We disagreed with this violation. The waste was profiled with a range (IE: yellow liquid 0- 25%) so the waste received description can seem subjective compared to the profile. 4. UDEQ alleged 2 drums of site generated waste were incinerated without burn chemistry documentation. The facility believes this was done but documentation could not be produced. Personnel involved were retrained. 5. There were seven additional examples of improper burn chemistry documentation violations. To address the issues, the waste analysis plan was recently modified that will allow burn chemistry 93 matrixes to be applied based on sampling and analysis of each waste stream. This information is documented in the operating record. 6. UDEQ alleged the facility did not properly completed inspection logs. During this timeframe, a new electronic inspection log was implemented. One day the log would indicate an issue and the next day it passed. The problem was attributed to a pop up warning that did not properly function. This was promptly corrected. 7. UDEQ alleged that crack repairs to a secondary containment system was a violation. We disagreed with this violation. The cracks were found during an inspection. They could not be repaired within 72 hours as required by permit due to weather. UDEQ was notified prior to 72 hours as required by the permit. The cracks were promptly repaired when the weather was dry and >50⁰F. (needed for the epoxy to cure) 8. UDEQ alleged the facility did not report a fire as required by the permit. We disagreed with this violation. A hose connected to a propane torch became disconnect causing an incidental fire. The permit requires any fire in an area where waste is managed to be reported. The fire did not meet reporting required by the permit. 9. UDEQ alleged an instrument calibration log was not signed by the technician who did the calibration. The person did not sign the log as required. He was retrained. This was resolved by a consent order that included a $35,017 penalty. In 2012 EPA issued a warning letter alleging seven instances of TRI reporting errors from 2007 through 2010. These mistakes were made by a former employee who is no longer employed by Clean Harbors. This was resolved by a consent order that included a $39,900 penalty. Questions associated with this fact sheet should be directed to Mike Crisenbery, VP Compliance (513-823- 2280). 94 Curtis Bay Energy LP Penalty Record Date Type Summary Detail Fine Amount Return to Compliance Date Corrective Action March 2015 Air HCI Emissions failure was caused by incomplete Trona injection, CO Emissions failure was caused by incomplete combustion of the waste, and Opacity Emission. Failure was caused by bag malfunction Hydrogen Chloride (HCl), Carbon Monoxide (CO), and opacity limit exceedance fine amount $125,000, settlement $50,000 January 2016 i. HCl Emissions failure was addressed Installation of a DSI (Dry Sorbent Injection System) ii. CO failure was addressed by implementing better engineering practices and installing a new conveyor system for providing enhanced blended for better emissions control. iii. Opacity Emissions Failure was corrected with ongoing preventive maintenance of the bags. 95 Daniels Sharpsmart, Inc. Fresno, California Transfer Facility Penalty Record Date Address Regulatory Body/Agency Finding 5/28/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Failed to provide tracking documents which show the name, address, and telephone number of the medical waste generator, for purpose of tracking the generator medical waste when the waste is transported to the final medical waste treatment facility. 5/28/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Containers to be reused were not thoroughly washed and decontaminated by a method approved by the Department and maintained in a clean and sanitary condition. 5/28/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Tracking documents are not staying with the waste and are being signed off as treated by the office staff. 5/28/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Unregistered haulers are used to transport waste out of the state for incineration. 8/26/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Waste is not being held at 32°F or below. 96 Date Address Regulatory Body/Agency Finding 8/26/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Containers to be reused were not thoroughly washed and decontaminated by a method approved by the Department and maintained in a clean and sanitary condition. 8/26/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health The facility shall immediately clean the ground around the treatment area to a well-maintained condition. Any enclosure or designated accumulation area used for storage of medical waste prior to transportation or treatment shall provide medical waste protection from animals and natural elements and shall not provide a breeding place for insects or rodents. 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Failed to provide tracking documents which show the name, address, and telephone number of the medical waste generator, for purpose of tracking the generator medical waste when the waste is transported to the final medical waste treatment facility. 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Waste is not being treated within the required timeframe. 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Containers to be reused were not thoroughly washed and decontaminated by a method approved by the Department and maintained in a clean and sanitary condition. 97 Date Address Regulatory Body/Agency Finding 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health A new operations manual must be submitted within 30 days. 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Tracking documents are not staying with the waste and are being signed off as treated by the office staff. 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Unregistered haulers are used to transport waste out of the state for incineration. 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Not all incineration waste is being treated by incineration. 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Not all pathology waste is being treated in a mixture of 25% pathology and 75% biohazardous waste as required. 98 Date Address Regulatory Body/Agency Finding 11/20/2014 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Non-compliances with the conditions of the permit were not reported to the Department within 24 hours. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Failed to provide tracking documents which show the name, address, and telephone number of the medical waste generator, for purpose of tracking the generator medical waste when the waste is transported to the final medical waste treatment facility. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Waste is not being treated within the required timeframe. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Waste is not being held at 32°F or below. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Containers to be reused were not thoroughly washed and decontaminated by a method approved by the Department and maintained in a clean and sanitary condition. 99 Date Address Regulatory Body/Agency Finding 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Some waste containers are being compromised and pose an environmental risk. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Some pharmaceutical waste containers, individual, secondary or the fiberboard boxes did not have the proper labeling. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Autoclavable waste in the recycled sharps program was not treated within the required seven days. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Tracking documents are not staying with the waste and are being signed off as treated by the office staff. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Not all incineration waste is being treated by incineration. 100 Date Address Regulatory Body/Agency Finding 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Not all pathology waste is being treated in a mixture of 25% pathology and 75% biohazardous waste as required. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Did not request both the shipping and tracking documents from the transporters delivering waste to the transfer station. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Tracking documents do not meet the requirements of the Code of Federal Regulations (CFR) for the DOT shipping documents. 4/10/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health The findings by the Department on November 20, 2014 that the autoclave computer was not consistently printing the time/temperature readings have not been corrected. 5/20/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Some pharmaceutical waste containers, individual, secondary or the fiberboard boxes did not have the proper labeling. 101 Date Address Regulatory Body/Agency Finding 5/20/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Develop a process for ensuring that all documents are completely and accurately filled out and that it is clear where the waste is being transferred for out of state treatment. 5/20/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Did not request both the shipping and tracking documents from the transporters delivering waste to the transfer station. 5/20/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Tracking documents do not meet the requirements of the Code of Federal Regulations (CFR) for the DOT shipping documents. 5/20/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health The findings by the Department on November 20, 2014 that the autoclave computer was not consistently printing the time/temperature readings have not been corrected. 11/2/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health A few sharpsmart transport carts were missing from the facility. 102 Date Address Regulatory Body/Agency Finding 11/2/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Sanitec totes used to store and transport pathology waste to Healthwise for treatment were not labeled nor had tight fitting lids. 11/2/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Tracking documents are not staying with the waste and pharmaceutical containers were not secure. 11/2/2015 4144 Therese Ave Fresno, CA 93725 California Department of Public Health Develop a process to ensure that documentation is as accurate as possible. 103 Appendix L Education and Outreach Call Center Script Thank you for calling the information line for the Medication Education and Disposal Project, or MED- Project. Call Script: • If you are experiencing a medical emergency, please hang up and dial 9-1-1. • If you are experiencing a non-emergency but suspect that you or a family member has ingested something poisonous, please call Poison Control at 800-222-1222. • Unwanted Medicine Kiosks are located throughout your local area and provide convenient options for disposing of expired or Unwanted Medicines. Press 3 for more information about convenient kiosks. • Mail-Back Services are available to Residents. Press 4 for more information. • Take-Back Events may be scheduled throughout the year and offer residents a free and convenient way to dispose of expired or Unwanted Medicine. Press 5 for more information. 104 • A Sharps Program is available in your local area and provides convenient options for disposing of unwanted sharps. Press 6 for more information. • You may press 0 at any time to speak with an operator about disposal options. • MED-Project is a consumer education campaign dedicated to proper medication use and consumer disposal. • MED-Project reminds you that taking your medicine as directed by your health care provider is important to your health. • If you have questions about your medication, please hang up and call your health care provider. • For additional questions about the proper disposal of expired or unwanted medications from households, please go to www.med-project.org or press 0 to talk to an operator. • To hear this menu again, please press 1. • Thank you for calling MED-Project. Unwanted Medicine Kiosk Script for when Option 3 is selected: • Kiosk Drop-Off Sites for Unwanted Medicine are located conveniently throughout your local area. To locate the site nearest you, or for precise information about hours of operation, press 0 to speak with an operator or visit www.med-project.org to search by your zip code. • Kiosks accept medications in any dosage form in their original container or sealed bag. Items that are not accepted include herbal remedies, vitamins, supplements, cosmetics or other personal care products; medical devices; batteries; mercury-containing thermometers; sharps; and illicit drugs. • If you transfer your medications to a sealed bag before placing it into a kiosk, please be sure to recycle all remaining packaging. • To protect your privacy, remove or black out all personally identifiable information before disposing of your medications or recycling your drug packaging. • To repeat this information, press 3. • To return to the main menu, please press 1. • Thank you for calling MED-Project. Unwanted Medicine Mail-Back Services Script for when Option 4 is selected: • Mail-Back Services for unwanted medicine and inhalers are available to disabled and home-bound Residents, persons providing services to such Residents, and Residents in underserved areas of the County. • Unwanted Medicine Mail-Back Packages accept medications in any dosage form in their original container or sealed bag. Items that are not accepted include herbal remedies, vitamins, supplements, cosmetics or other personal care products; medical devices; batteries; mercury- containing thermometers; sharps; and illicit drugs. • To request a Mail-Back Package, please press 0 to talk to the operator or visit www.med- project.org. • If you transfer your medications to a sealed bag, please be sure to recycle all remaining packaging. • To protect your privacy, remove or black out all personally identifiable information before disposing of your medications or recycling your drug packaging. • To repeat this information, press 4. • To return to the main menu, please press 1. • Thank you for calling MED-Project. 105 Unwanted Medicine Take-Back Event Script for when Option 5 is selected: • MED-Project may be working with local law enforcement and other community organizations to offer regular expired and Unwanted Medicine Take-Back Events in your area. For a complete list of Take-Back Events, please press 0 to speak to the operator or visit www.med-project.org. • Take-Back Events accept medications in any dosage form in their original container or sealed bag. Items that are not accepted include herbal remedies, vitamins, supplements, cosmetics or other personal care products; medical devices; batteries; mercury-containing thermometers; sharps; and illicit drugs. • If you transfer your medications to a sealed bag, please be sure to recycle all remaining packaging. • To protect your privacy, remove or black out all personally identifiable information before disposing of your medications or recycling your drug packaging. • To repeat this information, press 5. • To return to the main menu, please press 1. • Thank you for calling MED-Project. Sharps Program Script for when Option 6 is selected: • Kiosks to collect unwanted sharps are located throughout your local area. To locate the kiosk site nearest you, or for information about kiosk locations, press 0 to speak with an operator, or visit MED-Project.org to search by zip code. • Sharps Mail-Back Services1 for sharps are available to disabled and home-bound Residents or to persons providing services to such Residents. To request a Sharps Mail-Back Package, press 0 to talk to the operator or visit MED-Project.org. • Sharps such as hypodermic needles, pen needles, intravenous needles, pre-loaded sharps, auto injectors, intravenous needles, lancets and other devices used to penetrate the skin for drawing blood, or for the delivery of medications or drugs contained in approved sharps containers may be turned in at kiosks or placed in a Sharps Mail-Back Package. • MED-Project cannot accept controlled substances, shaving razors, loose needles, unwanted medicine not contained in sharps, or loose sharps that are not contained in approved sharps containers. Approved sharps containers must be made of a heavy-duty plastic; able to close with a tight-fitting, puncture-resistant lid, without sharps being able to come out; upright and stable during use; leak-resistant; and properly labeled as “sharps waste” or with the biohazard symbol and the word “BIOHAZARD”. • MED-Project is working with community organizations to offer Sharps take-back events in your area. For a complete list of take-back events, please press 0 to speak to the operator or visit MED- Project.org. • To protect your privacy, remove or black out all personally identifiable information before disposing of your medications. • To repeat this information, press 6. • To return to the main menu, press 1. • Thank you for calling MED-Project. 1 Sharps Mail-Back Services is the provision of pre-paid, pre-addressed packages to disabled and home-bound Residents for the collection and disposal of Sharps (“Sharps Mail-Back Packages”) by Vendor. Sharps as defined in Section 6.54.030 of the Alameda County Safe Consumer-Generated Sharps Disposal Ordinance, Alameda County Code Chapter 6.54 are “devices with sharp points or edges that can cut or puncture the skin and includes needles, pen needles, syringes, lancets, auto-injectors, infusion sets, intravenous catheters, connection needles/sets, and other devices.” 106 Appendix M MED-Project Website 107 108 109 110 111 112 113 114 115 Appendix N Brochure 116 117 Appendix O Digital and Local Social Networks The following is a representative list of local organizations and their social media networks in the County. MED-Project will reach out to relevant groups to help promote the Program. OUTLET FACEBOOK TWITTER 510 Families https://www.facebook.com/510Families @510families Alameda Alliance https://www.facebook.com/alamedaallianceforhealth @AlamedaAlliance Alameda Blogs @Alamedans Alameda Buzz @AlamedaBuzz Alameda County https://www.facebook.com/AlamedaCounty @Alameda County Alameda County Fair https://www.facebook.com/alamedacountyfair @ACFair Sutter Health https://www.facebook.com/SutterHealth @SutterHealth Alameda Health Consortium https://www.facebook.com/alamedahealthconsortium Alameda Health System https://www.facebook.com/AlamedaHealthSystem @AlamedaHealth Alameda Patch https://www.facebook.com/AlamedaPatch @AlamedaPatch Alameda Rotary Club https://www.facebook.com/RotaryClubofAlameda @alamedarotaryclub Alameda-Contra Costa Medical Association https://www.facebook.com/Alameda-Contra-Costa-Medical- Association-148916421860535/?ref=br_rs @EastBayDocs Albany Patch https://www.facebook.com/AlbanyCAPatch/?ref=br_rs @AlbanyPatch CA Medical Assn https://www.facebook.com/cmaphysicians @cmaphysicians City of Fremont https://www.facebook.com/cityoffremont @Fremont_CA California Pharmacist Association https://www.facebook.com/CAPharm @CAPharm 118 California Nurses Association https://www.facebook.com/nationalnurses @NationalNurses National Association of Social Workers California https://www.facebook.com/naswca @naswca City of Hayward https://www.facebook.com/cityofhayward @cityofhayward City of Livermore https://www.facebook.com/cityoflivermore @cityoflivermore City of Oakland https://www.facebook.com/oakland/ @CityofOakland City of Union City https://www.facebook.com/CityofUnionCity @UnionCity_Gov Downtown Oakland Association https://www.facebook.com/downtownoak/ East Bay Loop https://www.facebook.com/eastbayloop/ @EastBayLoop Eastmont Wellness Center https://www.facebook.com/pages/Eastmont-Wellness- Center/131624876909152?ref=br_tf Fremont Patch Foundation https://www.facebook.com/FremontCAPatch @FremontPatch Livermore Library https://www.facebook.com/pages/Livermore-Public- Library/99365063645 @livlibrary Oakland Local https://www.facebook.com/oaklocal @oaklandlocal Oakland Magazine https://www.facebook.com/oaklandmagazine @eastbay365 Oakland Police Department https://www.facebook.com/oaklandpoliceca/ @oaklandpoliceca Oakland Public Library https://www.facebook.com/oaklibrary @oaklibrary