Thank you to our sponsors! Platinum Gold National Association of Clean Water Agencies Waste Treatment Division, King County, WA San Francisco, CA – Department of the Environment San Benito County Integrated Waste Management Hazardous Waste Management Programs, King County, WA Idaho Department of Environmental Quality King County Solid Waste Division, WA Los Angeles County Sanitation Districts, CA Minnesota Pollution Control California Integrated Waste Management Board Silver Santa Monica, CA Snohomish County Solid Waste District, WA City of Palo Alto, CA Environmental Compliance City of Palo Alto, CA Central Vermont Solid Waste Management City of Santa Rosa, CA Central Contra Costa Sanitary District, CA Veolia ES MedServe

PSI National Dialogue on Pharmaceuticals Sacramento, CA June 19-20, 2008

What is the Product Stewardship Institute? Non-profit, based in Boston, founded in 2000 Membership 44 State members 54 Local agency members 20 Adjunct Council members Board of Directors: 7 states, 4 local agencies Multi-stakeholder product stewardship network Adjunct Council: businesses, environmental/other org’s

PSI Full and Affiliate State Members

Why was the Product Stewardship Institute Created? Unified voice for State and Local governments Fiscal relief for government on waste issues Objective data for decision-making Forum for collaboration with industry Nationally coordinated systems/harmonized regulations

PSI Projects Pharmaceuticals Medical sharps Fluorescent lamps Mercury thermostats Paint Electronics Radioactive devices Telephone books Gas cylinders Tires Beverage containers Packaging Batteries Motor oil

What is Product Stewardship? “Product Stewardship" is a principle that directs all those involved in the life cycle of a product to take shared responsibility for reducing the health and environmental impacts that result from the production, use, and end-of-life management of the product.

PSI Role in Dialogue Research Facilitate/mediate dialogue meetings Implement projects & initiatives Evaluate projects

Process for Developing Action Plan Draft Problem Statement and Goals Issues/Strategies Interviews/input from stakeholders Input incorporated into Action Plan Draft Action Plan distributed - June 30 Input & additions to draft – due July 31 NOT PSI’s Issue Statement and Goals

PSI’s “Agenda” Promote product stewardship solutions Reduce product impacts Forge partnerships that share responsibility Product management Sustainable financing Emphasize producer responsibility Get results – not just discussion

Meeting Objectives General agreement on: Confirm road map Stakeholder roles/process Issue statement Dialogue focus Dialogue goals Confirm road map

Meeting Objectives Greater understanding of other perspectives Explore shared interests and ways to move forward Determine next steps Meeting date/location Stakeholder assessment

Stakeholder Roles Authorized to represent company, agency, or organization. Attend 4 meetings (or via phone). Active participation in and between meetings. Jointly develop agreement. Ensure your interests/others’ interests are met. Participation in dialogue does not preclude legislative activity, other initiatives. Negotiate in good faith. Trust the process.

Press Role Use information discussed at meeting for background only. No direct quotes from meeting of any participant. Opportunity for quotes from participants outside of meeting discussion (breaks or post-meeting).

Consensus All participants can live with decision and no one will actively block or undermine decision. The greater the stakeholder agreement, the greater the likelihood that the agreement will be sustainable.

Consensus Consensus is preferable for broad initiatives: Technical standards Policies Legislation or regulatory changes Consensus is NOT needed for pilot projects or individual initiatives.

Road Map START Workgroup Activity Dialogue Meeting MEETING 4 AGREEMENTS 2 Workgroups Develop findings Draft work plans Finalize agreements Develop Implementation Plan MEETING 1 Refine draft agreements START MEETING 3 Present Workgroup findings/plans Discuss additional strategies Start to develop draft agreements MEETING 2 Workgroup Activity Refine Workgroups Develop Findings Draft work plans Present Workgroup findings/plans Discuss additional strategies Dialogue Meeting June 2008 Sep/Oct 2008 January 2009 March 2009

Possible Dialogue Outcomes Joint research (“joint fact-finding”). Pilot projects with measurable results (data). Demonstration project to test comprehensive program. Model state or national education campaign.

Possible Dialogue Outcomes State or federal regulatory or policy changes. Model state or federal legislation. National sustainable financing system for the management of pharmaceuticals.

Possible Mechanisms for Agreements Letter of agreement between those involved in pilot project. Memorandum of understanding (MOU) between stakeholders stating intent to perform certain activities.

What do we want to avoid? Multiple state solutions. Unilateral state or federal regulation.

Issue Statement – Pharmaceuticals Save lives, improve quality of life. Already wide use is increasing (and number of products). Become waste as they expire or are no longer needed/wanted. Enter the environment through a variety of pathways, primarily human/animal excretion.

Issue Statement – Pharmaceuticals Growing concern over potential for misuse, abuse, poisonings, etc. of waste/unwanted medications. Growing concern over presence of pharmaceuticals in waterways (potential for human health and environmental impacts).

Issue Statement – Pharmaceuticals Currently, there is a lack of agreement as to whether waste pharmaceuticals should be collected in drug take-back programs for disposal.

Issue Statement – Pharmaceuticals The debate over whether take backs are warranted has led to confusion over what message to provide the public regarding the safest way to dispose of waste pharmaceuticals.

Issue Statement – Some believe… Current state of science does not warrant collection. Question whether take backs have environmental or safety benefit since data show that most drugs entering waterways are derived through normal use and excretion.

Issue Statement – Some believe… Question whether enough of the public would use take back systems, further nullifying any potential benefit. Believe that people misuse drugs whether or not they are wastes, and that take backs would not reduce the incidence of drug abuse.

Issue Statement – Others believe… Take backs are necessary to protect against unsafe storage practices that have resulted in accidental poisonings, overdoses, thefts, diversions, and deaths, and to reduce pharmaceuticals entering the environment.

Issue Statement – Others believe… Industry take-back programs already exist in Canada and Europe, so why not the U.S. While the science regarding environmental impact is uncertain, the potential scope of the problem could be immense, and therefore justifies invoking the “precautionary principle.”

Issue Statement – Others believe… If they are convinced that a problem exists and they want their citizens and patients protected, regulations should be changed to allow programs for the collection of residential pharmaceuticals that are not unnecessarily inefficient, costly, or burdensome.

Issue Statement – Pharmaceuticals While there is an emerging consensus that flushing unwanted pharmaceuticals down toilets is not recommended, there is disagreement over whether disposal in the garbage represents safe disposal.

Fundamental Questions Why go through the trouble of educating consumers not to flush if there are no aquatic or human health impacts? Is there a societal benefit to reduce the amount of waste/unwanted medications? Is there a societal benefit to collect waste/unwanted medications once generated? Can waste pharmaceuticals be safely disposed of in the home?

Dialogue Focus This project will focus on unwanted or waste pharmaceutical products from residential sources (e.g., households, nursing homes, hospice care, long-term care facilities, schools, cruise ships, hotels, and pet care facilities).

Dialogue Focus The project will specifically address the proper management of unused pharmaceuticals that typically enter the municipal solid waste stream, municipal wastewater, or residential septic systems. 

Dialogue Focus The project will not focus on personal care products or non-pharmaceutical endocrine disruptors

Dialogue Focus It will not focus on problems related to the use of pharmaceuticals, although the impacts of dispensing and use practices that are relevant to the generation of unwanted and waste pharmaceuticals will be explored.

Dialogue Goals Evaluate the need for a nationally coordinated system for the management of unwanted/waste pharmaceuticals that allows for multiple solutions to reflect local/regional differences. Increase the safe, legal, and environmentally-protective management of unwanted/waste pharmaceuticals through the development of best management practices.

Context for Collaboration Some want more research to better understand the nature and scope of the problem. Some are implementing take-back programs. Some states are introducing legislation. Given differences in opinions, are there areas of potential collaboration?

Potential Area of Collaboration: Joint research Quantity and type of waste/unwanted medications. Extent of accidental poisonings, overdoses, thefts, diversions, and deaths attributable to waste/unwanted medications in the home. Percentage of pharmaceuticals in home storage attributable to normal use vs. waste/unwanted medications.

Potential Area of Collaboration: Joint research Percentage of pharmaceuticals entering waterways attributable to excretion vs. other pathways. Impact on aquatic species and potential impact on human health. What are the reasons and attitudes behind household storage and disposal practices and preferences?