The Story of SB 212 - Bringing Producer Funded Pharmaceutical and Sharps to California 

State and local governments in the United States followed the lead of Canada, France, Spain, and others to implement pharmaceutical EPR laws and local ordinances. In 2018, California passed national precedent for an statewide EPR program for pharmaceuticals and sharps. For over ten years prior, CPSC helped pass several local ordinances and shared insight with other states to build momentum that lead to the passage of the statewide program. Each of the local ordinances are described below with chronological history and relevant  supporting documents.

 

SB 212 was sponsored by Senator Hannah-Beth Jackson (Santa Barbara) and was signed by Governor Brown in September 2018. The legislation is in the regulatory process as the designated agency, CalRecycle, establishes the regulations to carry out the directives of SB 212. 

To learn more about the problems caused by improper disposal of pharmaceuticals and other health products such as sharps, read CPSC’s “A Prescription for Change” publications below.

 

First California County to Pass a Pharmaceutical EPR Program: Alameda County, California

On July 24, 2012, Alameda County adopted the Safe Drug Disposal Ordinance. This ordinance is based on the program in British Columbia, operated by many of the same pharmaceutical companies doing business in the U.S. This precedent setting ordinance was the first in the nation to hold pharmaceutical companies responsible for the safe collection and disposal of unused medications from the public, starting with a challenge by the pharmaceutical industry in December of 2012 and two appeals which resulted in the U.S. Supreme Court denying the request to hear the case on May 26, 2015.

Alameda Safe Drug Disposal Ordinance Timeline:

  • 1/26/18: Alameda County adopted proposed revisions to the 7/24/2012 Safe Drug Disposal Ordinance. Key changes in the revisions include:

    • Adds Over-the-Counter (OTC) medications to the covered items

    • Allows for collection of Controlled Substances at both law enforcement AND DEA registrants (Pharmacies and Hospitals)

    • Requires the stewardship organization to provide a kiosk to any DEA Registrant even if they have reached the 110 site goal originally stated

    • Minor changes to definitions to clarify ordinance, and make enforcement easier

  • 5/26/15: U.S. Supreme Court denies petitioners’ Writ of Certiorari (request to hear case)

  • 4/15/15: Alameda responds to Supreme Court questions

  • 2/25/15: Director of the Department of Environmental Health approves the two stewardship plans that were submitted.

  • 2/23/15: Alameda County Safe Drug Disposal Program Public Hearing to review submitted product stewardship plans

  • 12/29/14: PhRMA and other plaintiff organizations file a Petition For Writ of Certiorari asking the U.S. Supreme Court to consider the case – Petition text

  • 9/30/14: Ninth Circuit Court of Appeals rules for Alameda County – Court ruling

  • 7/11/14: Ninth Circuit Court of Appeals hearing video (the hearing starts around the 1:01:50 mark)

  • 9/12/13: Notice of appeal is filed by PhRMA and other plaintiff organizations in the Federal Court of Appeals

  • 8/28/13: US District Judge Richard Seeborg finds the ordinance constitutional in the 9th circuit court

  • 12/7/12: Alameda County is sued by three organizations representing the pharmaceutical industry

  • 7/24/12: Safe Drug Disposal Ordinance is adopted by unanimous vote by the Alameda County Board of Supervisors

Other Alameda resources:

 

Pharmaceutical EPR Programs in Local Counties in California

Information below is for each county in California that has an Extended Producer Responsibility (EPR) model ordinance for safe medicine and sharps disposal.

 

City & County of San Francisco, California

In 2010, San Francisco introduced a Safe Drug Disposal Ordinance. However, in 2012 the city chose to instead accept $110,000 from PhRMA and Genentech to fund a pilot project to collect data on the issue. In August 2013 the same two organizations provided another payment of $125,000 to fund the pilot project an additional year. A separate Safe Drug Disposal Information Ordinance was passed in May 2011 to supplement the PhRMA-funded pilot program by requiring pharmacies that won’t host a bin to advertise those that do.

The Safe Medicine Disposal Pilot program has been well-utilized, with over 37,000 pounds collected in the first 26 months.

Following the U.S. 9th Circuit Court of Appeals ruling upholding Alameda’s ordinance, San Francisco Board President David Chiu reintroduced the Ordinance on October 21, 2014. Board President Chiu was elected to the California State Assembly in November 2014 and Supervisor London Breed became the author of the ordinance and was elected President of the Board of Supervisors. The ordinance was heard in committee on February 26th with a 3 – 0 vote to move the ordinance to the full Board. The ordinance was heard before the full Board twice – once on March 10, 2015 where it received an 11 – 0 vote to adopt and again on March 17, 2015 where it received a second and final unanimous vote to adopt. San Francisco Mayor Edwin Lee signed the legislation on March 26, 2015 and the ordinance’s date of enactment is 30 days after signing.

 

Contra Costa County, California

  • 12/20/16 – Final Safe Drug Disposal ordinance adopted on consent. Ordinance is effective 30 days from passage. County staff will return to the Board with an update before July 2017 and work to address multiple additional items including the makeup of the Stewardship Organization that implements the program to be listed as a 501-c3 and adding specificity to the method of medication disposal.

  • 12/13/16 – Motion to waive the ordinance reading and fix 12/20/16 as the adoption date of the revised ordinance passes unanimously by 5-0 vote.​


San Mateo County, California


Santa Barbara County, California

 

Santa Clara County, California

  • CPSC Fact Sheet on Santa Clara’s Pharmaceutical and Sharps EPR Ordinance– Revised 8/27/18

  • 3/7/18- The County of Santa Clara Board of Supervisors has passed a law (Ordinance No., NS-517.92) requiring sharps manufacturers and pharmaceutical companies who produce and distribute medicines that require home injection to submit and implement a comprehensive plan for safe disposal of consumer-generated sharps waste.

  • 3/14/17 – Ordinance to amend the existing Safe Drug Disposal Ordinance in order to clarify and strengthen ordinance requirements prior to implementation of MED-Project’s proposed stewardship passed by a 3-0 vote with two Supervisors recusing themselves.

  • 5/19/15 – Ordinance introduced at Board of Supervisors Meeting and passed by a 3-0 vote with two Supervisors recusing themselves due to pharmaceutical investments.  6/23/15 – Ordinance second reading before Board and received a unanimous 3 – 0 vote to adopt, with two Supervisors recusing themselves due to pharmaceutical investments. 7/23/15 – ordinance went into effect.

  • Resources:

 

Marin County, California

 

Los Angeles County, California

 


Santa Cruz County, California

 

Sonoma County, California

 

San Luis Obispo County, California

  • 3/11/15 – Ordinance passed by the the San Luis Obispo County Integrated Waste Authority (IWMA) Board of Directors by an 11-0 vote with two Directors absent.  Ordinance is “Transitional to EPR” policy since a different group in the product chain – in this case retailers – is having to pay for the program but not producers.  4/11/15 – Ordinance takes effect. Effective 9/11/15, retail pharmacies in the IWMA region are required to provide a mail back program and/or collection receptacle program to dispose of unwanted prescription drugs as required under the Ordinance

  • 1/10/2018 – Full EPR Ordinance passed by the IWMA shifts the cost burden of the program to the producers.

 

Tehama County, California

  • 7/3/18 –  Ordinance passed by the Tehama County Board of Supervisors by a 4-1 vote.  The ordinance covers both medications and sharps and is the first to require the stewardship organization to be an IRS c3 to promote public benefit and be transparent as a non profit.  This is the first rural county to pass an ordinance with both medications and sharps collection paid for by producers.

 

Pharmaceutical EPR Programs Around the Country​​​​​​​​​​​​​​

New York State

  • 7/11/18 – Drug Take Back Act Take Back Act passes. Key points from the act include that ALL pharmacies must participate and the collection of sharps are not included.

 

Washington State

 

King County

On June 20, 2013 the King County Board of Health in Washington passed the Secure Medication Return Rule & Regulation to create a drug take-back program for King County residents. The program promotes the safe disposal of unused prescription and over-the-counter drugs, and will be funded and operated by the drug manufacturers. On November 27, 2013 four groups of major drug manufacturers sued the County. The suit was dismissed following the U.S. Supreme Court’s 5/26/2015 decision not to hear industry’s legal challenge to the Alameda County Safe Drug Disposal Ordinance.

Status – On October 16, 2015, King County approved the Return Meds LLC stewardship plan and rejected the King County MED-Project LLC stewardship plan. The MED-Project submitted a revised proposed stewardship plan for review in accordance with the December 14, 2015 deadline. The compliance deadline for the approved stewardship plan to be fully implemented is no later than April 13, 2016.

Washington County

Additional Washington Counties with EPR medicine disposal ordinances: Kitsap (2016), Pierce (2016), Snohmish (2016), Whatcom (2017), Clallam (2017)​

 

This video describes the drug manufacturers’ MED-Project program that is working in Snohomish and King counties under their Secure Medicine Return ordinances. The WA Secure Drug Take-Back Act (SHB 1047) is modeled on these successful local laws.

Pharmaceutical EPR Programs Around the World​​​​​​​​​​​​​​

  • South America

    • Brazil – Descarte Consciente

    • Colombia – Punto Azul

      • Administered by Colombia’s National Association of Entrepreneurs (ANDI), the Punto Azul program began collecting medicines in 2010 with funding supplied by pharmaceutical manufacturers and importers. Collection is located at pharmacies and large supermarkets but is not mandatory. In 2014 there were over 685 locations nationally covering 43% of the population.

      • CPSC Program Fact Sheet

  • Other Resources

Sharps EPR in the United States

Alameda County

The County of Alameda passed an EPR ordinance for sharps on 11/15/15. The ordinance requires producers that sell sharps in Alameda County to participate in a product stewardship plan for the collection and disposal of sharps. The ordinance went into effect on 12/18/15.

 

By June 18, 2016 sharps producers must notify the County of their intent to participate in a product stewardship plan. Proposed product stewardship plans must be submitted to the County by December 18, 2016. More information is available on Alameda County Environmental Health’s Safe Drug and Consumer-Generated Sharps Disposal webpage.

 

Santa Cruz County

The County of Santa Cruz passed an EPR ordinance for pharmaceuticals and sharps on 12/8/15. The ordinance requires producers that sell sharps in Santa Cruz County to participate in a product stewardship plan for the collection and disposal of sharps. The ordinance went into effect on 1/8/16.

 

By March 1, 2016 sharps producers must submit proposed product stewardship plans to the County for review and approval.

 

San Luis Obispo County

In 2008 the County of San Luis Obispo adopted a “transitional EPR” sharps management ordinance, setting up a program for the public to conveniently and safely take back used sharps to a retailer, free of charge. The ordinance places the responsibility for providing sharps take back on the retailers with no funding from industry or other members of the product chain. In January, 2018, San Luis Opispo passed a full EPR ordinance, requiring manufactures to pay and manage the pharmaceutical and sharps waste in the county.

 

Santa Clara County

In 2018, the County of Santa Clara Board of Supervisors has passed an ordinance (No. NS-517.92) requiring sharps manufacturers and pharmaceutical companies who produce and distribute medicines that require home injection to submit and implement a comprehensive plan for safe disposal of consumer-generated sharps waste. This ordinance builds upon the County’s success of the existing Safe Drug Disposal Ordinance, first passed in 2015 and revised in 2017, which provides safe, free and convenient drop-off of unwanted or expired medications. See the County Press Release for more information.

 

Transitional EPR Local Programs for Sharps

A “Transitional” EPR legislation/policy requires that other members of the product chain but not the producers themselves take responsibility for end-of-life management of the product. In California transitional EPR policy has typically impacted retailers but in other countries different members of the product chain have been included.

 

City of Sacramento

In 2010, Sacramento adopted a sharps take-back ordinance that required all retail stores, hospitals, and other points of sale or distributors of sharps for home use in the City to take back sharps at no additional cost to the customer at the time of return.

 

Tulare County  

In 2014 the Tulare County JPA and eight other cities in the county adopted sharps take-back Ordinance, modeled after the 2008 San Luis Obispo ordinance, which provide no-cost sharps take-back to Tulare residents. The ordinances require pharmacies and pet stores, among other retailers of sharps in Tulare County, to establish a system for collection of home-generated sharps waste in their retail outlet.

 

Santa Cruz County 

In August 2014 the Santa Cruz County Board of Supervisors adopted a sharps take-back ordinance, which requires every retailer and provider of sharps in the unicorporated area of the county to provide at no-cost a sharps take-back program to residents. The ordinance requires pharmacies and pet stores, medical or veterinary offices, clinics, hospitals and approved needle exchange programs located in the unincorporated area of the county to establish a system for collection of home-generated sharps waste on site during normal hours of operation. The ordinance provides several options for compliance.  The ordinance takes effect September 5, 2014 with businesses required to establish collection programs by October, 1, 2014.

 

City of Galt

On October 20, 2015 the Galt City Council adopted a sharps take-back Ordinance which requires retailers selling needles within the City to provide safe disposal for their customers. The ordinance takes effect November, 20, 2015 with businesses required to establish collection programs by January 20, 2015.

 

Del Norte County

CPSC partnered with the Del Norte Solid Waste Management Authority (DNSWMA) on a grant to foster more product take-back programs. CPSC and DNSWMA developed outreach materials to educate the citizens of the County on proper sharps disposal and to help them to protect their neighbors and community from needlestick injuries.

 
 

What is extended producer responsibility (EPR)?

Extended Producer Responsibility (EPR), also known as Product Stewardship, is a strategy to place a shared responsibility for end-of-life product management on the producers, and all entities involved in the product chain, instead of the general public; while encouraging product design changes that minimize a negative impact on human health and the environment at every stage of the product's lifecycle. This allows the costs of treatment and disposal to be incorporated into the total cost of a product. It places primary responsibility on the producer, or brand owner, who makes design and marketing decisions. It also creates a setting for markets to emerge that truly reflect the environmental impacts of a product, and to which producers and consumers respond.

Source:  CalRecycle

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