EPR for Medications What Up & What s Next December 4, 2014 Los Angeles Regional Agency

EPR for Medications What Up & What s Next December 4, 2014 Los Angeles Regional Agency

Product Stewardship Institute 2 What is EPR/PS? Product Stewardship Extended Producer Responsibility (EPR)

EPR Principles Key Points Producer Designed, Funded, Operated Producer Responsibility Producers are required to design, manage, and finance programs for end-of-life management of their products and packaging as a condition of sale. These programs may or may not use existing collection and processing infrastructure. Programs should cover (orphans). Level Playing Field All producers within a particular product category have the same requirements Transparency and Accountability Government is responsible for ensuring that producer programs are transparent and accountable to the public. Producer programs, including their development and the fate of products managed, provide opportunity for input by all stakeholders.

EPR Principles Key Points (cont.) Results-based Producers have flexibility to design the product management system to meet the performance goals established by government, with minimum government involvement. Producer-managed systems must follow the resource conservation hierarchy of reduce, reuse, recycle, and beneficially use. Products must be managed in a manner that is protective of human health and the environment. Producers design and implement public education programs to ensure achievement of performance goals and standards established by government. All consumers have convenient access to collection opportunities without charge

Principles Key Points (cont.) Roles for Government, Retailers and Consumers Government is responsible for ensuring a level playing field for all parties in the product value chain to maintain a competitive marketplace with open access to all, for setting and enforcing performance goals and standards, for supporting industry programs through procurement, and for helping educate the public. Retailers only sell brands within a covered product category that are made by producers participating in an industry program, and are responsible for providing information to consumers on how to access the programs. Consumers have a responsibility to reduce waste, reuse products, use take-back and other collection programs, and make appropriate purchasing decisions based on available information about product impacts and benefits. Maybe We Should Call it Shared Responsibility?

A look at state EPR laws for multiple products 24 around the nation 14 3 5 8 10 72 EPR laws in 32 states (including carpet, cell phones, and agricultural pesticide containers) plus one Framework law 6

CPSC Mission Goals of EPR To shift California s product waste management system from one focused on government funded and ratepayer financed waste diversion to one that relies on producer responsibility in order to reduce public costs and drive improvements in product design that promote environmental sustainability.

EPR Resolutions As of October 8, 2014 137 resolutions have been passed by local jurisdictions and organizations supporting product stewardship representing 64% of Californians! Key to City & County Resolutions: County is a member of an association 1 that has passed an EPR resolution or policy statement, but has not individually passed an EPR resolution County has individually passed an EPR resolution City has passed an EPR resolution Three major local government associations have all adopted resolutions in support of EPR: California State Association of Counties League of Cities Regional Council of Rural Counties

CPSC Partners Platinum Partner We are very proud to join a growing list of local governments, associations, and companies that support CPSC and its efforts. This fits in nicely with our mission of being an industry-leader in managing waste materials. We are not just waste haulers anymore; we are waste stream materials managers, protecting today s environment for a better tomorrow. Johnnie Perkins, Corporate Director of Public Sector Services Copyright 2010 California Product Stewardship Council

CPSC Partners (10/28/14) Platinum Partners Edgar Institute Marin Sanitary Service Republic Services UltiMed Gold Partners California Refuse Recycling Council California Resource Recovery Association Green Cities California Recology

CPSC Partners (10/29/14) Silver Partners CalRecycle* Carton Council Bronze Partners Acrylatex Biologic Ecology Action FlameKing Los Angeles Fiber Peninsula Packaging Company Potential Industries Inc. PSC Environmental Services South San Francisco Scavenger Company, Inc. Visions Paint Recycling, Inc. Zanker Disposal and Recycling * CalRecycle has not signed the CPSC Pledge, since this would be inappropriate for a State agency, but is a partner and financial supporter of CPSC. Funded by a grant from the Department of Resources Recycling and Recovery (CalRecycle)

Strategic Directive 5 February 2007 * CalRecycle will Seek statutory authority to foster cradle-to-cradle producer responsibility. Develop relationships with stakeholders that result in producer-financed and producer-managed systems * Formerly the California Integrated Waste Management Board Slide12

What Does CPSC Want? For Problem Products Cost-effective programs that work (each product is different) Performance based programs Smaller government role, private sector designed and managed Shared responsibility (define) Producers/others to collaborate on solutions Products designed for composting/recycling

Canadian Stewardship of Meds Industry Stewardship Plan Develop program plan Implement program Administer program Reporting

Epidemic: Responding to America s Prescription Drug Abuse Crisis 2014 National Drug Control Strategy: 1. Education of health providers and the public. 2. Expand prescription monitoring programs. 3. Safe drug disposal increase return/take-back and disposal programs. 4. Effective enforcement to address pill mills and doctor shopping. 17

Drugs in Water Statewide Campaign CASA, EPA, SWRCB + dozens of local agencies Joint legislative proclamation by Senate and Assembly 65 official partners 2 kickoff press events, PSAs, ads and media statewide

Don t Rush to Flush Campaign twitter.com/dontrushtoflush www.facebook.com/dontrushtoflush www.dontrushtoflush.org

CA. Leg/Reg Activity Which Guided Local Initiatives CA SB 966 (Simitian) 2007 Developed model program guidelines 2010 Report to the legislature encouraged extended producer responsibility (EPR) legislation AB 1442 (Weikowski) 2012 Amended Med Waste Mgmt Act - Allows common carrier transport (instead of costly medical waste haulers) of pharma waste CA SB 1014 (Hannah - Beth Jackson) 2014 EPR bills for pharmaceuticals SB 727 2013

2006: One day collection events More than 1,000 lbs. collected Temporary Pharmacy Collection Temporary Pharmacy Collection Convenient location No sustainable funding source Not permanent

Mail-In Program Mail-In Program No controlled Mail substances back envelopes: 2009-2011 No sustainable More funding than source 2,550 lbs. collected Expensive -- $3.25 EACH

DEA Collection Events DEA Collection Events No sustainable funding source Not permanent DEA Collection events since 2010 More than 1,400 lbs. collected

2010: San Francisco Safe Drug Disposal Ordinance SUSPENDED DUE TO PHARMA FUNDING SF develops a Stewardship Plan template with metrics Producers submit plan describing collection system, convenience, outreach and performance SF approves the plan Producers submit an annual report, including volumes Phased-In: Prescription, non-prescription, controlled substances

Voluntary Collaborative Pilot Funding ($110,000 in 2011 and another $125K in 2013) From PhRMA and Genetech Collection Program Logistics Outreach

SF Drug Disposal Information Ordinance All pharmacies conduct outreach posted in an area visible to the public & adjacent to the area where prescription drugs are dispensed

IMAGE OF POLICE STATION COLLECTING MEDS All 10 police stations collect unwanted medicine, including controlled substances

SF residents love pharmacies! 2000 1800 1600 1400 1200 1000 800 600 Pharmacies DEA Days Police Stations 400 200 0

San Fran Pilot: Weight collected 23,304 pounds collected in 16 months

San Francisco Program: Lessons Learned Convenience: pharmacies (93% vs. police stations 7%) Completeness: police depts. for controlled's Permanence: manufacturer involvement Metrics, Outreach, Oversight: Govt? Costs: Forecast for this gov t run program is future operating costs $250K/year to maintain 15 collection locations with outreach campaign. Waste Characterization Study: http://www.sfenvironment.org/download/san-francisco-medicine-wastecharacterization-study

The County Drafted the Ordinance 3 2 First Public Hearing Date 2/28/12 County Supervisors Public Meeting Passed First Reading Second Reading Held 3/13/12 Due to industry complaints about process, Supervisors did not adopt and instead scheduled series of educational hearings to allow further input and deeper discussion

3 3 Held Five Stakeholder Meetings

Public Communication Community Organizers Alameda County Medication Education Disposal Safety Coalition (MEDS) Alameda County Departments California Product Stewardship Council (CPSC) videos https://www.youtube.com/user/calpsc/vide os?sort=dd&shelf_index=3&view=0 3 4 Social Media Facebook: www.facebook.com/alamedasafemeds Twitter: http://twitter.com/alcosafemeds Press Op-Eds Radio interviews AP and Reuters wire stories CPSC and Clean Water Action Fund Sierra Club E-Mail Blasts and Newsletters Grassroots Teleosis and Senior Advocacy

3 5 Two Hearings Led to the Adoption of the Ordinance

3 6 Supporters

Alameda County Pharmaceutical Ordinance First EPR Ordinance in US Adopted 7/12 Follows the BC model of roles of government and industry Requires producers to design, fund and operate the collection system Submittal of stewardship plan to Dept. of Environmental Health Environmental Health Department Oversight, approves Plan PhARMA and California associations of medical producers opposed any solution indicating there is no problem

Alameda Ordinance Facts Producer of a covered drug (not OTCs) sold in Alameda County must either operate or have an agreement with a Product Stewardship organization operating on their behalf No point of sale or point of collection visible fee - Producers are free to raise prices on drugs sold in Alameda County to cover the costs of the product stewardship program as a normal cost of doing business. Producers/Stewardship organization must pay Alameda County s costs for administration and enforcement

Alameda Ordinance (cont.) Stewardship Plan Stewardship plan will accept all unwanted products regardless of who produced them Description of collection methods Description of how the plan will be convenient, available in all areas of the county, and be adequate to meet the needs of the population. List of disposal sites

Alameda Ordinance Links Alameda County Environmental Health Safe Drug disposal program webpage http:///www.acgov.org/aceh/safedisposal/index.htm Safe Drug Disposal Liaison Email address safedrugdisposalliaison@acgov.org DEA Controlled substances disposal draft regulations http://www.deadiversion.usdoj.gov/fed_regs/rules/2012/fr1221_8.htm Examples of stewardship organizations: Product care http://www.productcare.org/ Paintcare http://paintcare.org/ Call2Recycle http://www.call2recycle.org/ Canadian program: http://www.healthsteward.ca/

Article in the New York Times 12/7/12 quotes complaint: The household trash can is a better and safer alternative, the drug makers say Three organizations filed lawsuit: Pharmaceutical Research and Manufacturers of America (PhRMA), General Pharmaceutical Association & Biotechnology Industry Association Filed in Federal Court claiming violation of the Commerce Clause of the Constitution Alameda County Prevailed in 9 th Circuit Court 8/29/13! Then Pharma Appealed 9/12/13 in Federal Court of Appeals Alameda County won Appeal 9/30/14

King County Board of Health Legislative body that sets county-wide policies to promote the health of King County residents. Board Chair Councilmember Joe McDermott Subcommittee on Secure Medicine Return July 2013, collected input from stakeholders through fall of 2012. Policy discussions October 2012 through April 2013. Public hearing held May 16 th on draft legislation. Public hearing & adoption on June 20, 2013 Boardmember Mayor David Baker http://www.kingcounty.gov/healthservices/health/boh/medicin etakeback.aspx

SB 1014 EPR for Medications Mirrors Alameda Ordinance, added OTCs Held in Senate Environmental Quality Committee Stakeholder negotiation meetings Contact Linda Barr at Senator Jackson s office 916-651-4536 Linda.Barr@sen.ca.gov

National News Attention National Public Radio, January 2014

National News Attention Wall Street Journal, April 2014

Appealed to Federal 9 th Circuit 9th Circuit Court of Appeals - 3 judge panel 7/11/14 No new facts only interpretation of law Judge I have a feeling this may not be the last word on this Court sides with Alameda County, upholds ruling 9/30/14

San Francisco Reintroduces Meds EPR Ordinance 10/21/14

Prescription for Change: Sacramento News & Review Insert March 2014 Meds and Sharps

What is CPSC Doing? Education

Join CPSC Heidi Sanborn Executive Director Heidi@CalPSC.org 916-706-3420 www.calpsc.org Connect!