Beginning January 1, 2019, a new California law establishes extensive requirements for proper management of waste pharmaceuticals and “sharps.” These new provisions complement – but aren’t actually well-connected to -- medical waste management requirements (I outlined typical state-based requirements here), and workplace provisions to protect workers from “bloodborne pathogens” that may be present because of health and medical procedures and the wastes they generate (I discussed OSHA’s “BBP” Standard here). The rest of this note summarizes these new requirements, adopted by Senate Bill (SB) 212 (Jackson).
Solid Waste Management in California
Since January 1, 1990, California’s comprehensive state framework for management of non-hazardous wastes is provided by the California Integrated Waste Management Act of 1989 (the State Act). The State Act is assigned to the California Department of Resources Recycling and Recovery (CalRecycle), which administers statewide programs, and also oversees local agencies delegated to perform planning and regulatory activities.
State policies call for the proper management of solid wastes, including not only safe disposal but recycling and source reduction efforts intended to reduce the volumes requiring disposal. Many are framed as “diversion” – i.e., diversion of wastes that would otherwise go to landfills – and CalRecycle reports that overall statewide diversion rates have risen to over 60% since the policies began in 1989. In order to support ever-increasing diversion rates, the State Act has been amended repeatedly in recent years to create targeted requirements for recycling, post-use reuse and/or manufacturer take-back of particular wastestreams. Specialized programs address each of the following: used oil, used and waste tires, electronic waste, cell phones, non-hazardous batteries, carpets, architectural paint, and mattresses. The new requirements for pharmaceuticals and sharps provide the latest such targeted program.
The New Law
The new law defines who and what is regulated, and assigns responsibilities. CalRecycle is to adopt regulations for implementation of this legislation, effective by January 1, 2021. The State Board of Pharmacy may also adopt regulations.
- Definitions
Requirements apply to “covered entities,” which are defined as the manufacturers of “covered products” sold in or into California. If no California-based manufacturer can be identified, then responsibilities devolve down the supply chain to the first of the following that does exist in California: distributor that is licensed as a wholesaler; repackager; owner or licensee of a trademark or brand; or importer.
A “covered product” means a covered drug or home-generated sharps waste. A “covered drug” means:
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A drug, including brand name or generics, sold or offered for sale or dispensed in California, including prescription and non-prescription drugs approved by the Food and Drug Administration (FDA), drugs marketed pursuant to an over-the-counter monograph, and drugs in medical devices
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But does not include vitamins and supplements; herbal-based and homeopathic remedies; cosmetics, soap, laundry detergent, bleach, household cleaning products, shampoos, sunscreens, toothpaste, lip balm, antiperspirants, or any other personal care product that is regulated as both a cosmetic and a nonprescription drug; drugs already subject to a stewardship or take-back program under an FDA managed risk evaluation and mitigation strategy; specified types of biological drug products; medical devices, including components and accessories; drugs used for animal medicine; and dialysate drugs and other saline solutions used for kidney dialysis.
“Home-generated sharps waste” means hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications derived from household, including a multifamily residence or household.
- Providing lists of covered products
By April 1, 2019, each covered entity is to provide CalRecycle a list of covered products, and a list and description of any drugs and sharps that are not covered products. In subsequent years, each covered entity or stewardship program representing covered entities (see below) is to provide updated lists each January 15.
By April 1, 2019, each retail pharmacy that sells a covered product under its own label must provide CalRecycle a written notification identifying the covered entity from which the covered product is obtained. The State Board of Pharmacy (the Board) is to verify the information in these lists and notifications, and can request information (including proprietary information) from any covered entity to do so, and make verification information available to CalRecycle on request. The Board is to notify CalRecycle of any covered entity or stewardship organization it finds to be in violation of these requirements.
- Stewardship programs for covered drugs
Covered entities can create and operate their own stewardship program, or can join a stewardship organization that will do so. Within 6 months after CalRecycle adopts its regulations, each stewardship program operator must submit to CalRecycle a complete stewardship plan the meets applicable requirements. Program operators are to “fully implement” each approved stewardship program within 270 days after CalRecycle’s approval. To be complete, a stewardship plan for covered drugs must do all of the following:
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Identify and provide contact information for the program operator and each participating covered entity, and identify each covered drug sold or offered for sale by each participating covered entity.
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Identify and provide contact information for the authorized collectors for the stewardship program, including reasons if any potential authorized collectors were excluded.
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Include any determinations of noncompliance provided by a state agency, accompanied by a superseding determination of compliance.
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Demonstrate adequate funding for all administrative and operational costs of the stewardship program, to be borne by participating covered entities.
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Provide for a handling, transport, and disposal system that complies with applicable state and federal laws, including, but not limited to, regulations adopted by the United States Drug Enforcement Administration (DEA).
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Provide for a collection system meets specified requirements.
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Require a program operator to meet specified requirements for collection from ultimate users, including those who are homeless.
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Provide policies and procedures for the safe collection, transport, and disposal of the covered drugs.
At least 120 days before submitting its stewardship plan to CalRecycle, each stewardship program operator must inform potential authorized collectors of the opportunity to participate, and attempt to negotiate agreements with those that express interest. In any county with an insufficient number of authorized collectors, a program operator may supplement collections with mail-back programs or other alternative method that complies with DEA requirements.
- Stewardship programs for home-generated sharps
To be complete, a stewardship plan for home-generated sharps must do all of the following:
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Identify and provide contact information for the program operator and each participating covered entity, and identify each covered product sold or offered for sale by each entity.
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Include any determination of noncompliance provided by a state agency, accompanied by a superseding determination of compliance.
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Demonstrate adequate funding for all administrative and operational costs of the stewardship program, to be borne by participating covered entities.
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Provide for a handling, transport, and disposal system, at no cost to the ultimate user, that complies with applicable state and federal laws.
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Maintain an Internet website and toll-free telephone number to provide information on the program, including disposal options, and to receive requests for sharps waste containers from ultimate users.
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A stewardship program for home-generated sharps waste can be a mail-back program that meets specified requirements.
- Additional provisions
Stewardship plans must also include specified education and outreach programs. They must also include provisions for expansion into additional jurisdictions if another program is terminated.
The new law includes extensive provisions for budgeting and administration, within stewardship programs and at CalRecycle and the Board. Programs and agencies also have requirements to provide reports, including information on websites. Penalties are provided for noncompliance with this law. Stewardship programs must also comply with all other applicable state and federal laws, including DEA regulations.
What Happens Now?
Organizations in pharmaceutical supply chains should be preparing lists and determining whether to comply by themselves or join into stewardship organizations. Thoughtful employers should be considering pharmaceutical wastes from health and safety programs and any organizational health clinics, as well as preparing to pass information to individual employees who may generate sharps at home (such as employees with diabetes).
Also, readers should note that the US Environmental Protection Agency (EPA) announced final rules to complete a long rulemaking to establish “Management Standards for Hazardous Waste Pharmaceuticals” under the Resource Conservation and Recovery Act (RCRA). (I blogged about the proposal here, and have inserted EPA’s rulemaking webpage below).
Self-Assessment Checklist
Does the organization manufacture or distribute pharmaceuticals regulated under this new law?
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If so, is it preparing compliance – a list of products, establishment of or participation in a stewardship organization?
Does the organization use pharmaceuticals in its activities, as a health or medical care service provider and/or through clinics or similar operations on behalf of employees?
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If so, has it reviewed how waste pharmaceuticals are presently managed, and begun to prepare for opportunities for management that will be created in response to this law?
Does the organization provide information to employees and others about how to manage self-generated and home-generated sharps?
Where Can I Go For More Information?
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CalRecycle website
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California Board of Pharmacy website
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Alameda County (California) website for its (first-in-the-nation) Household & Small Business Hazardous Waste Collection Program
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SB 212 (text, on California Legislature website)
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EPA webpage for hazardous waste pharmaceutical rulemaking
Specialty Technical Publishers (STP) provides a variety of single-law and multi-law services, intended to facilitate clients’ understanding of and compliance with requirements.
About the Author
Jon Elliott is President of Touchstone Environmental and has been a major contributor to STP’s product range for over 25 years.
Mr. Elliott has a diverse educational background. In addition to his Juris Doctor (University of California, Boalt Hall School of Law, 1981), he holds a Master of Public Policy (Goldman School of Public Policy [GSPP], UC Berkeley, 1980), and a Bachelor of Science in Mechanical Engineering (Princeton University, 1977).
Mr. Elliott is active in professional and community organizations. In addition, he is a past chairman of the Board of Directors of the GSPP Alumni Association, and past member of the Executive Committee of the State Bar of California's Environmental Law Section (including past chair of its Legislative Committee).
You may contact Mr. Elliott directly at: tei@ix.netcom.com
photo credit: misterbisson down by the tracks via photopin (license)