BILL ANALYSIS Ó SENATE COMMITTEE ON ENVIRONMENTAL QUALITY Senator Wieckowski, Chair 2015 - 2016 Regular Bill No: AB 45 ----------------------------------------------------------------- |Author: |Mullin | ----------------------------------------------------------------- |-----------+-----------------------+-------------+----------------| |Version: |1/21/2016 |Hearing |6/29/2016 | | | |Date: | | |-----------+-----------------------+-------------+----------------| |Urgency: |No |Fiscal: |Yes | ------------------------------------------------------------------ ----------------------------------------------------------------- |Consultant:|Rachel Machi Wagoner | | | | ----------------------------------------------------------------- SUBJECT: Household hazardous waste. ANALYSIS: Existing federal law: 1) Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) is authorized to oversee the safety of food, drugs, and cosmetic products. 2) Under the Resource Conservation and Recovery Act (RCRA) of 1976, the management of solid and hazardous wastes is regulated. In the context of pharmaceuticals, RCRA imposes strict protocols for the collection of controlled substances. 3) The Secure and Responsible Drug Act specifies handling for controlled substances, amendments made in 2014 ease the restrictions on the collection of controlled substances. Existing state law: 1) Under the California Hazardous Waste Control Act (HWCA), the Department of Toxic Substances Control (DTSC) is authorized to regulate hazardous materials and wastes in accordance with RCRA and HWCA. 2) Under the California Integrated Waste Management Act: a) Requires the Department of Resources Recycling and Recovery (CalRecycle) to implement a statewide household AB 45 (Mullin) Page 2 of ? hazardous waste substance information and collection program. b) Requires cities and counties to prepare, adopt, and submit to CalRecycle a Household Hazardous Waste (HHW) Element plan which identifies a program for the safe collection, recycling, treatment, and disposal of hazardous wastes that are generated by households within the jurisdiction and provides a specific time frame for achieving these objectives. c) Requires CalRecycle and DTSC to jointly maintain a database of all HHW collection events, facilities, and programs within the state and make that information available to the public upon request. d) Requires CalRecycle to coordinate with DTSC to develop and implement a public information program to provide uniform and consistent information on the proper disposal of hazardous substances found in and around homes, and to assist the efforts of counties required to provide HHW collection, recycling, and disposal programs. e) Requires CalRecycle, upon appropriation by the Legislature, to distribute grants to cities, counties, or other local agencies with the responsibility for solid waste management, and for local programs to help prevent the disposal of hazardous wastes at disposal sites, which include, but are not limited to, programs that expand or implement HHW programs. f) Authorizes local jurisdictions to include in their HHW Elements a program for the safe management of sharps waste. g) Requires pharmaceutical manufacturers that sell or distribute a medication in California that is self-injected at home through the use of a hypodermic needle, pen needle, intravenous needle, or any other similar device to submit to CalRecycle a plan that describes what actions, if any, the manufacturer supports for the safe management of sharps AB 45 (Mullin) Page 3 of ? waste. 3) Under the Medical Waste Management Act (MWMA): a) Requires the California Department of Public Health (DPH) to regulate the management and handling of medical waste. b) Defines "pharmaceuticals" as a prescription or over-the-counter human or veterinary drug. "Pharmaceutical" does not include any pharmaceutical that is regulated pursuant to either RCRA or the Radiation Control Law and certain items, such as household waste, are specifically excluded from the definition of medical waste. c) Defines "medical waste" as including waste generated from the consolidation of home-generated sharps. d) Defines "pharmaceutical waste" as any pharmaceutical that for any reason may no longer be sold or dispensed for use as a drug and excludes from this definition those pharmaceuticals that still have potential value to the generator because they are being returned to a reverse distributor for possible manufacturer credit. e) Specifies that waste comprised only of pharmaceuticals is biohazardous, and is considered "medical waste." f) Defines "home-generated sharps waste" as hypodermic needles, pen needles, intravenous needles, lancets, and other devices that are used to penetrate the skin for the delivery of medications derived from a household, including a multifamily residence or household. g) Prohibits the disposal of home-generated sharps waste in the trash or recycling containers, and requires that all sharps waste be transported to a collection center in a sharps container approved by the local enforcement agency. h) Authorizes a registered medical waste generator to accept and consolidate home-generated sharps waste with the facility's medical waste stream under specified conditions. AB 45 (Mullin) Page 4 of ? This bill: 1) Requires CalRecycle, in consultation with affected industries, to adopt one or more model ordinances for a comprehensive program for the collection of HHW for adoption by a local jurisdiction that provides for the residential collection and disposal of solid waste. 2) Local jurisdictions proposing to enact an ordinance to govern the collection and diversion of HHW may adopt one of the model ordinances after CalRecycle has posted the model ordinances on its Internet Web site. 3) Expands the definition of HHW, for the purposes of this section, to include sharps and pharmaceutical waste. 4) Requires CalRecycle to determine if an appropriate nonprofit organization has been created and funded to make grants to local governments for specified activities relating to HHW programs. 5) Requires CalRecycle to consider a list of factors in making the determination about the nonprofit organization. 6) The provisions of this bill will be repealed on January 1, 2019, if CalRecycle does not make the determination that an appropriate nonprofit organization exists by December 31, 2018. Background Hazardous Waste. 1)Hazardous waste. Hazardous wastes are wastes with properties that make them dangerous or potentially harmful to human health or the environment. Hazardous wastes can be liquids, solids, contained gases, or sludges. They can be by-products of manufacturing processes or simply discarded commercial products, like cleaning fluids or pesticides. AB 45 (Mullin) Page 5 of ? 2)Household Hazardous Waste (HHW). HHW is hazardous waste commonly generated by households and includes such ubiquitous items as batteries, pesticides, electronics, fluorescent lamps, used oil, solvents, and house cleaners. Because these wastes can pose a threat to health and safety and the environment. In California, it is illegal to dispose of HHW in the trash, down the drain, or by abandonment. HHW needs to be disposed of through an HHW program. Cities and counties are required to prepare, adopt, and submit to CalRecycle, an HHW Management Element Plan, which identifies a program for the safe collection, recycling, treatment, and disposal of HHW. The Element Plan specifies how HHW generated within the jurisdiction must be collected, treated, and disposed. Each jurisdiction is required to prepare and implement plans to reduce and safely collect, recycle, treat, and dispose of HHW and provides a specific time frame for achieving these objectives. While there are many different approaches for the collection and management of HHW, all are permitted by DTSC and most are operated by local jurisdictions. Some private operators operate programs under contract with local jurisdictions, including curbside and door-to-door collection. Pharmaceutical Waste. 3) Pharmaceuticals. According to the U.S. Centers for Medicare & Medicaid Services, which publishes the National Health Expenditure Projections 2012-2022, approximately $275.9 billion in prescription drugs were predicted to be prescribed in the U.S. in 2014. However, 2014 expenditures were almost $100 billion more than predicted according to the IMS Institute for Healthcare Informatics. In an April 2015 study, IMS stated that spending rose 13%, to a total of $374 billion. After accounting for population growth and inflation, the increase equaled 10%. A record 4.3 billion prescriptions were AB 45 (Mullin) Page 6 of ? filled in 2014."These numbers do not reflect the purchase of over-the-counter medications (OTCs). a) Pharmaceutical contamination. There are two general sources of pharmaceutical contamination in the environment: human excretion and disposal. Estimates suggest that 3 to 50% of prescriptions become waste. United States hospitals and long-term care facilities annually flush approximately 250 million pounds of unused pharmaceuticals down the drain. It is unknown (if not impossible) to determine how much household pharmaceutical waste is flushed down the toilet. However, anecdotally waste water treatment facilities note that scraping pills off of water filtration systems is a problem, in addition to the removal of pharmaceutical agents from the water. A study conducted by the United States Geological Survey from 1999-2000 sampled 139 streams across 30 states and found that 80% had measurable concentrations of prescription and nonprescription drugs, steroids, and reproductive hormones. Since the USGS released its report in 2002, a number of studies have demonstrated the low-level presence of pharmaceutical agents throughout the environment and water supply. Recent studies have found a variety of drugs in crops, such as cholesterol medications, caffeine, and triclosan. In a recent study, researchers found that the anticonvulsive epilepsy drug, carbamazepine, can accumulate in crops irrigated with recycled water and end up in the urine of produce-eaters not on the drug. The researchers found that while the amounts of the drug in a produce-eater's urine were four orders of magnitude lower than what is seen in the urine of patients purposefully taking the drug, there is a possibility that trace amounts could still have health effects in some people, such as those with a genetic sensitivity to the drugs, pregnant women, children, and those who eat a lot of produce, such as vegetarians. With the growing practice of reclaiming wastewater for crop irrigation, the produce contamination could become more common and more potent. AB 45 (Mullin) Page 7 of ? California, which grows a large portion of US produce, currently uses reclaimed water for 6% of its irrigation needs. Additionally, as California's climate continues to change and the state endures longer droughts, recycling and reusing for groundwater and surface water recharge will become more important and ensuring contamination prevention and removal will be more crucial. While the human effects of pharmaceutical agents in the environment are not fully understood, harm to aquatic organisms and ecosystems due to low levels of pharmaceutical agents are clearly established. Life-long exposure to ppb levels of an estrogen-based synthetic hormone resulted in complete population failure in fish due to the males failing to develop properly. Mood altering drugs, such as Prozac, lead to changes in the behavior of fish, making them easier prey. The presence of persistent antibiotics, particularly downstream from hospitals, has been partially credited for the rise in resistant bacterial strains, which may also have an indirect human impact. b) Pharmaceutical Take-Back Programs. i) DEA Take-back programs. The DEA's Take-Back events are a significant piece of the White House's prescription drug abuse prevention strategy released in 2011 by the Office of National Drug Control Policy. "Drug Take-Back Days," which are typically administered by law enforcement in conjunction with county health offices or other local government agencies, are one-time events that allow for individuals to dispose of prescription or non-prescription medications; following the collection, the pharmaceuticals are taken to a safe disposal site. The DEA's seventh National Take-Back Day in October 2013 collected 324 tons of expired and unwanted medications across all 50 states. Since the inception of the National Take-Back Day in 2010, the DEA has collected over 3.4 AB 45 (Mullin) Page 8 of ? million pounds of medicine from circulation. ii) International take-back programs. In 1999, British Columbia established the "Post-Consumer Pharmaceutical Stewardship Association" (PCPSA) to establish a pharmaceutical drug take-back program funded by manufacturers. Manufacturers are required to pay for the cost of collecting and managing the program; they are not required to pay for cost of agency oversight. Currently, over 100 companies participate in the PCPSA. Within British Columbia, 95% of pharmacies choose to participate in the program, accounting for over 1,000 collection sites. In 2009, the program diverted 112,000 pounds of medication from improper disposal or abuse for an estimated cost of $400,000. Australia established a national collection system in place since 1998. The European Union has required a national collection system for unused or expired medicines since 2004. iii) Take-back programs in the US. Locally run take-back programs are prevalent throughout the US. A few states, such as Michigan and Maine, have enacted laws to facilitate the collection of pharmaceutical waste at locations such as pharmacies (MI) or to create mail-back programs for pharmaceutical waste (ME). In light of the new statute in Colorado, the Colorado Springs Airport has installed two marijuana take-back bins, providing a location for travelers to safely and legally dispose of their marijuana. Although recreational marijuana is legal in Colorado, it is highly regulated at the federal level and has a high diversion potential. iv) SB 966 Model Guidelines in CA. Under the California Integrated Waste Management Act (SB 966, Simitian/Kuehl, Chapter 542, Statutes of 2007), CalRecycle created a model collection program for household hazardous substances, such as pharmaceuticals, and evaluated how local programs implemented take-back programs. Programs that followed the model guidelines were released from any liability AB 45 (Mullin) Page 9 of ? associated with collecting home-generated pharmaceuticals. The model program sunsetted on January 1, 2013. CalRecycle's report to the Legislature on the pilot project, Recommendations for Home-Generated Pharmaceutical Collection Programs in California, recommends that proper drug disposal mechanisms be put in place on a statewide basis. v) Local programs in CA. In 2010, CalRecycle identified 297 take-back programs in California. This includes one-time take-back events, continuous take-back programs, and mail-back programs. The majority of these programs are funded and run by local governments, although San Francisco has a program that is partially funded by PhRMA and Genetech. Recently, Alameda County passed a first in the nation Safe Drug Disposal Ordinance that requires producers of covered drugs to operate take-back programs, including the creation, administration, promotion, and payment of the program. The ordinance was challenged by Pharmaceutical Research and Manufacturers of America, Generic Pharmaceutical Association, and Biotechnology Industry Organization on the basis that the ordinance violates the dormant Commerce Clause for interstate commerce and discriminates against out-of-county producers. In August 2013, the U.S. District Court upheld the ordinance, although litigation is ongoing. Several other California counties are considering or have enacted similar ordinances. Sharps waste. 4)Medical sharps: An estimated one million Californians inject medications outside traditional health care facilities, which generate approximately 936 million sharps each year, and the numbers of patients using injectable medications will continue to grow because it is an effective delivery method for various medications. The most common home use of sharps is to manage diabetes. Other reasons to inject at home include hepatitis, multiple sclerosis, infertility, migraines, allergies, hemophilia, and medications for pets. AB 45 (Mullin) Page 10 of ? a) Sharps Waste. According to statistics from CalRecycle, 43% of all self-injectors throw needles in the trash. According to CalRecycle's 2014 waste characterization study, 2014 Disposal-Facility-Based Characterization of Solid Waste in California, the composition of California's overall disposed waste stream is dissected by material type. There is not a line-item for home-generated sharps, but under the category of HHW is the subcategory "Remainder/Composite Household Hazardous," which includes household hazardous material that, if improperly put in the solid waste stream, may present handling problems or other hazards, such as pesticides and caustic cleaners, sharps, medications, and supplements. The 2014 report estimates that remainder/composite household hazardous materials comprises more than 94,000 lbs. (0.2%), of the total solid waste stream. b) Sharps risk: Improper sharps disposal can affect janitors, housekeepers, pest control workers, groundskeepers, waste management workers, and children or household pets among others. Roughly 25% to 45% of all facilities processing household trash (besides recycling) in California have workers hand-sorting recyclable material out of that trash. A single worker's on-the-job needle stick can mean weeks of taking drugs to prevent the spread of infection, with side effects including nausea, depression, and extreme fatigue as well as months waiting for expensive periodic tests to reveal whether they contracted life-threatening HIV/AIDs or hepatitis B or C. According to CalRecycle, it costs between $154 to $2,411 for testing/treatment for a single needlestick, and around $4.6 million is spent in California every year due to needlesticks, primarily for testing for infection and work loss while testing. c) In 2013, in connection with AB 1893 (Stone and Eggman) and a related Senate Labor Committee hearing, the Legislature requested that the Commission on Health and Safety and Workers' Compensation review whether provisions of current law offered sufficient protection against sharps injuries for workers outside healthcare occupations. As a result, the University of California, Berkeley (UC Berkeley) released a March 2015, study, Infection Risk from "Sharps" AB 45 (Mullin) Page 11 of ? Injuries for Non-healthcare Workers, which found a contrary view. That study stated, "sharps injuries, outside the healthcare setting are uncommon. About 1-in-10,000 workers outside healthcare will experience a needlestick in a given year. For specific industries (education, food & hospitality, and waste management) and occupations (custodial services and protective services), this risk is substantially higher. However, even in these specific industries and occupations, the risk of a sharps injury is less than 1/1000 workers/year." d) Sharps collection: Home-generated sharps waste is required to be put into an approved sharps container before being transported out to an approved drop-off location or via mail-back program. CalRecycle maintains the Facility Information Toolbox (FacIT) Website, which currently lists more than 600 facilities where residents can take their home-generated sharps such as hospitals, pharmacies, or HHW facilities. While disposal of sharps is illegal, there is no statutory program in place to require the management of sharps by manufacturers, pharmaceutical companies, pharmacies, or others. Current law allows for a streamlined oversight structure for those that do wish to provide a voluntary disposal for sharps to their customers or the general public, but there is no mandate for them to do so. Some pharmacies and health care providers have developed programs as a way to assist their customers and have reported some success. Currently, out of California's 58 counties, three counties (Tulare, San Luis Obispo, and Santa Cruz) and two cities (Galt and Santa Cruz) have an ordinance that has some level of requirements on retail establishments that sell sharps to accept the used sharps for proper disposal. Other jurisdictions are considering a similar ordinance. According to CalRecycle, approximately 50 counties provide free disposal. At least eight counties and some cities provide free sharps containers and one county provides free mail-back containers to its residents as long as supplies last. AB 45 (Mullin) Page 12 of ? e) Sharps collection requirements under the Medical Waste Management Act (MWMA): DPH has the authority to approve locations as points of consolidation for the collection of home-generated sharps waste, which, after collection, is transported and treated as medical waste. An approved consolidation location is known as a "home-generated sharps consolidation point." A home-generated sharps consolidation point must comply with all of the following requirements: (1) All sharps waste shall be placed in sharps containers; and (2) sharps containers ready for disposal shall not be held for more than seven days without the written approval of the enforcement agency. f) Current requirements for sharps manufacturers: Pursuant to SB 486 (Simitian, Chapter 591, Statutes of 2009), a pharmaceutical manufacturer that sells or distributes a medication in California that is intended to be self-injected at home through the use of a hypodermic needle, pen needle, intravenous needle, or any other similar device, is required to submit a plan to CalRecycle that describes the actions taken by the manufacturer to support or provide for the safe collection and proper disposal of the waste devices, and educate consumers about safe sharps management and collection opportunities. To date, CalRecycle has received sharps collection and disposal plans from 29 pharmaceutical manufacturers or distributors. According to the analysis of SB 486, "?with the prohibition of disposal of sharps in the waste stream and no convenient, cost effect [sic] method of management identified, it is time to take steps to find a solution of the problem. The first step to that is to identify what the companies that manufacture the medicines that are dispensed through a 'sharp' are doing to help their customers address the disposal ban issue? The author's office believes that this bill represents a first step toward developing an EPR [Extended Producer Responsibility] approach to the management of sharps, and provides a way to determine what the pharmaceutical industry is doing to assist with the effort to manage sharps." In the opinion of the Monterey Regional Waste Management AB 45 (Mullin) Page 13 of ? District, the voluntary provisions of SB 486 are not working. As of July 1, 2012, there were 31 plans submitted to CalRecycle, which were read and graded by a 9-person evaluation team, scoring each plan based on published consumer criteria. The Senate Bill 486 Evaluation Team Consumer Report Card found that, of those 31 manufacturer reports, 20, or nearly 65% of all submitted reports, were graded an F. In addition, 8 other manufacturers were graded "F/Incomplete" for not submitting plans by the legislatively mandated deadline of July 1 and being in violation of state law. Waste Management. 5)Waste management. Managing the waste stream is a very expensive and often burdensome task for local governments. Cities and counties spend upwards of $500 million annually to manage products prohibited from landfills as well as those lawfully disposed of at the landfill -- a cost that local governments ultimately pass along to the consumer in the form of fees on solid waste services. The environmental impacts of improper disposal are serious in their own right, but they also serve as a warning and potential threat on human health and safety. This creates an incredible public health and environmental burden for federal, state and local governments to attempt to deal with difficult, cumbersome or dangerous waste streams. In the last 3 decades, California has adopted and implemented a multitude of policies and laws aimed at lessening the impacts of waste, to reduce, reuse and recycle as much as possible. As California's waste management policies have evolved so has the discussion of responsibility for the costs associated with waste reduction and disposal. Many policies developed today are aimed at a shared responsibility between the consumer, private and public sectors with the goal of creating a holistic understanding and commitment to better design and products that do not harm public health or the environment from the beginning to the end of their lifecycle. Over the years, CalRecycle's predecessor, the California Integrated Waste Management Board, engaged in a variety of program activities concerning products and their impact on the AB 45 (Mullin) Page 14 of ? environment. These efforts continue as CalRecycle seeks a comprehensive approach for advancing efficient, effective shared waste management solutions, building upon the efforts elsewhere in the world. Most CalRecycle activities in the past have focused on better managing the impacts of product discards, rather than focusing on how to eliminate waste in the first place. Extended producer responsibility (EPR) is a waste reduction strategy. By shifting costs and responsibilities of product discards to producers and others who directly benefit, EPR provides an incentive to eliminate waste and pollution through product design changes. It allows CalRecycle to better carry out its mission for the citizens of California. In February 2007, the California Integrated Waste Management Board adopted a set of Strategic Directives that included Strategic Directive 5: Producer Responsibility: This policy directs staff to seek statutory authority to foster "cradle-to-cradle" producer responsibility and develop producer-financed and producer-managed systems for product discards. 6)Waste-Management Theories. a) Extended producer responsibility: CalRecycle defines EPR as 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. By shifting costs and responsibilities of product disposal to producers and others who directly benefit, EPR provides an incentive to eliminate waste and pollution through product design changes. AB 45 (Mullin) Page 15 of ? There are a number of existing, statewide EPR programs for various products, including, but not limited to, paint, used oil, and, most recently, mattresses. EPR, and take-back laws in particular, provides that manufacturers should be forced to internalize disposal costs and environmental externalities associated with their products. EPR involves: 1) the shifting of responsibility (physically and/or economically; fully or partially) upstream toward the producer and away from the municipalities; and, 2) to provide incentives to producers to incorporate environmental considerations in the design of their products. b) Product Stewardship. Product Stewardship is closely related to EPR. Product stewardship programs usually involve voluntary approaches and multi-stakeholder dialogues between state governments, industry, and consumer and environmental groups to arrive at better management practices for particular products. Product stewardship differs from EPR in that responsibility is shared across the chain of custody. c) Advance Recovery Fee (ARF). A consumer-financed ARF is an alternative to producer-financed systems. Typically, retailers forward the proceeds to a governmental authority that would fund municipal collection centers and subsidize private recycling operations to make recycling economical. Tax incidence theory holds that some of the ARF would actually be absorbed by manufacturers or retailers, so the burden of funding the new recycling infrastructure would be shared. In California, e-waste is an example of an ARF program. From the perspective of state and local governments, ARFs may be considered beneficial because they provide a steady source of revenue to fund the recycling infrastructure needed to manage waste, including "historic waste" which are used products already on the market when an ARF is enacted. In California, local governments are generally responsible AB 45 (Mullin) Page 16 of ? for dealing with the illegal dumping of mattresses, which can be costly to the local governments. For example, the author notes that the City of Oakland currently picks up and disposes of approximately 18 to 35 illegally dumped mattresses per day, which annually costs the city $501,355. Many manufacturers favor an ARF as well, because it leaves producers out of the collection and recycling process and may lead to a steady supply of subsidized secondary materials. An ARF helps consumers understand that there is a real environmental consequence and disposal cost for products that they purchase. Such a fee also helps provide consumer awareness that pollution is not solely caused by industrial firms, but by individual consumption decisions as well. Comments Purpose of Bill. 1)Purpose of the bill. According to the author, disposal of unused drugs and used sharps is a legitimate issue that the Legislature has attempted to address without success. The author states that local jurisdictions have attempted to address the issue as well, with mixed results. Industries within the medication and sharps supply chain believe they can be helpful to local jurisdictions in their efforts to manage these products, but believe the type of partnership set forth in the bill will yield better results and foster a more productive working relationship. Industry proponents want to place a moratorium on adoption of local ordinances mandating industry responsibility for a five-year period to see if this approach can be successful. The author believes the effort to address the issue of management of disposal of these products has become incredibly contentious and has not resulted in effective mechanisms for disposal. The author further states that these products do not fit neatly into that concept, which has resulted in management approaches that can be very expensive and difficult to implement and manage. In addition, the author feels the premises upon which many ordinances are based are not supported AB 45 (Mullin) Page 17 of ? by the facts. The author believes that programs at the local level that might well be effective would benefit from assistance from industry that is principally focused on consumer education and targeted support for disposal infrastructure. 2)Bill in print. AB 45 requires CalRecycle to adopt one or more model ordinances for a comprehensive program for the collection of household hazardous waste (as defined by this bill), and allows a local jurisdiction to adopt one of the model ordinances. Requires CalRecycle to determine whether an appropriate nonprofit organization has been created and funded for the purpose of making grants to local governments to assist with educating residents of communities on the existence of HHW disposal programs and how to use them; and, defray the cost of components of local government HHW programs. There are numerous concerns that range from the construct of how the bill is written to the specific policy provisions of the current bill that would make it difficult, if not impossible, to implement the legislation. The most concerning provisions are as follows: a) Model ordinances. Over the last several decades CalRecycle, DTSC and local governments have been contemplating and developing model solutions for the different regions of the state for different waste streams that reflect the emerging needs of California communities. While developing and making available a menu of model solutions is valuable to advise local jurisdictions in constructing their own solutions for safely and effectively executing their waste management mandates, it is not necessary or constructive to limit those solutions to new ordinances. As stated, local governments are already required to create waste solutions and have been doing so for many decades, to limit the tools for integrating new solutions to ordinances as specified by CalRecycle does not provide local jurisdictions the needed flexibility to manage their programs. AB 45 (Mullin) Page 18 of ? b) Non-profit. The bill contains a lack of specificity around what the non-profit identified in this bill would be and how it would be overseen by or accountable to the state for allocating grants. Additionally, the bill does not require that the non-profit be created. If it is created but found by CalRecycle to be "inappropriately" created or insufficiently funded then the provisions of this bill cease to exist as of January 1, 2019. Legislation is not needed to create optional non-profit granting entities. The industry could do this today. The only reason to put this provision in legislation is to make the non-profit grants contingent on a legislatively mandated prohibition on local governments adopting their own ordinances for the management of pharmaceutical and sharps waste. It would be inappropriate for the Legislature to trade local government control over how local jurisdictions comply with the mandate that they safely and effectively collect and dispatch these difficult waste streams in exchange for an optional grant program that would be controlled and implemented by the pharmaceutical industry. Additionally, a grant program that focuses on an educational campaign does not help local governments develop effective new solutions for the waste. c) Grant Funding. The bill specifies that $5 million dollars would be made available to implement a grant program for educating residents of communities on the existence of HHW disposal programs and how to use them; and, defray the cost of components of local government HHW programs. As outlined in the background, one of the difficulties AB 45 (Mullin) Page 19 of ? in successful collection and disposal of HHW, pharmaceutical waste and sharps waste is participation. Low consumer participation rates are not attributed to a lack of willingness or education on the part of the consumer. Rather, the problem is the lack of resources to make the myriad solutions developed to date conveniently and readily available to consumers and to implement newly emerging solutions. This is illustrated in the high participation and collection rates of the many take-back days conducted across the state as well as the solutions that have been in existence in other countries for many years. Additionally, defraying the current costs associated with HHW local programs does not help create expanded or new solutions to encourage greater and more success participation. 3)Suggested Amendment. The bill in its current form does not reflect the direction that California and its local elected governments have chosen to evolve waste management policy for the best protection and service to the state and its communities. The bill should be amended to strike the current contents of the bill and replace with language that will help Californians develop successful and efficient solutions for handling HHW, pharmaceutical and sharps waste streams that result in increased successful collection of HHW, pharmaceutical waste and sharps waste. Given the extensive amount of work done at both the state and local levels to review, research and develop efficient, effective and safe waste management strategies, what is needed at this juncture is the opportunity to test new as well as proven strategies in various types of communities to inform future government policies for waste management of HHW, pharmaceutical and sharps waste. The bill should be amended to create a pilot project in Los Angeles to develop and implement various strategies for different communities for HHW, pharmaceutical waste and sharps waste AB 45 (Mullin) Page 20 of ? that are aimed at increasing participation and providing safe and effective options for the appropriate handling of these waste streams. (Because of the sheer size and demographic of the many communities in Los Angeles County, this county is a good microcosm of the state to test strategies.) The pilot is to be created by CalRecycle in consultation with DTSC. CalRecycle will create an advisory committee for the pilot that consists of CalRecycle, DTSC, County of Los Angeles, other local government representatives, industry representation and other entities that can advise on waste management strategies. The pilot will be executed by the County of Los Angeles, if the county agrees, through a grant of $3 to 5 million a year for 3 years from participating pharmaceutical companies. The pilot shall include periodic reports as well as a final report (as specified by CalRecycle) that outlines the success of the various strategies implemented in the pilot including tracking of participation rates and other data as deemed appropriate by CalRecycle. While Los Angeles County is conducting this pilot project, the county and the municipal jurisdictions within the county shall not adopt ordinances for the disposal of pharmaceutical waste that are paid for at the direct cost of the pharmaceutical industry. Related/Prior Legislation AB 2039 (Ting, 2016) proposes building on the models of the aforementioned programs to develop EPR for home-generated medical sharps. This bill was referred to the Assembly Committee on Environmental Safety and Toxic Materials. Hearing was cancelled at request of the author. SB 1229 (Jackson/Stone, 2016) would provide that an entity AB 45 (Mullin) Page 21 of ? registered with the federal Drug Enforcement Agency to receive a controlled substance for the purpose of destruction is not liable for civil damages, or subject to criminal prosecution, for maintaining a secure drug take-back bin on its premise. SB 1229 passed out of the Senate Judiciary Committee on a vote 9-0. AB 649 (Patterson, 2015) requires Department of Public Health (DPH) to evaluate and approve an alternative medical waste treatment method that is designed to treat pharmaceutical waste by June 1, 2017, and would limit the use of such a technology by a law enforcement agency. AB 649 was held in the Senate Appropriations Committee. AB 1159 (Gordon/Williams, 2015) proposed establishing a pilot product stewardship program for the management of medical sharps and household primary batteries. It was approved by the Assembly Environmental Safety & Toxic Materials Committee on April 28, 2015 by a 6-0 vote. AB 1159 was held in the Assembly Appropriations Committee. SB 225 (Wieckowski, Chapter352, Statutes of 2015) makes various technical changes to the Medical Waste Management Act (MWMA). AB 2371 (Mullin, 2014), as heard by the Assembly Local Government Committee, would have required each jurisdiction, no later than January 1, 2016, to review its HHW Element to determine its effectiveness in the collection, recycling, treatment, and disposal of HHW, and would have required CalRecycle, on or before January 1, 2017, to submit a report to the Legislature that analyzes the effectiveness of the state's HHW management system. AB 2371 was later amended to deal with a different subject matter. AB 1727 (Rodriguez, Chapter 155, Statutes of 2014) restricts certain pharmaceuticals from county operated prescription drug collection and redistribution programs. AB 45 (Mullin) Page 22 of ? AB 1893 (Stone/Eggman, 2014) proposed requiring customers be given a free sharps disposal container with the sale of 50 or more medical sharps for self-injection. AB 1893 was pulled by the author from the Assembly Floor. ACR 93 (Buchanan, Chapter 23, Statutes of 2014) would declare March 2014 as Drug Abuse Awareness Month in California, and encourage all citizens to participate in prevention programs and activities and to pledge to "Spread the Word? One Pill Can Kill." SB 1014 (Jackson, 2014) requires the Department of Resources Recycling and Recovery (CalRecycle) and the California State Board of Pharmacy to jointly develop regulations authorizing a voluntary program to collect and properly dispose of home-generated pharmaceutical waste. SB 1014 was referred to the Assembly Appropriations Committee. Hearing was cancelled at request of the author. AB 403 (Stone/Eggman, 2013) proposed requiring manufacturers that sell medical sharps to establish a product stewardship plan for home-generated medical waste. AB 403 was held in the Assembly Appropriations Committee. AB 333 (Wieckowski, Chapter 564, Statutes of 2013) makes various changes to the Medical Waste Management Act. AB 467 (Stone, Chapter 10, Statutes of 2013) creates a licensure category for a surplus medication collection and distribution intermediary. SB 727 (Jackson, 2013) requires a producer of a pharmaceutical sold in this state, individually or through a stewardship organization, to submit a plan to CalRecycle by January 1, 2015. This bill was referred to the Senate Environmental Quality Committee. Hearing was cancelled at request of the author. AB 1442 (Wieckowski, Chapter 689, Statutes of 2012) defines pharmaceutical waste, exempted the waste generator from certain hauling requirements, and allowed the waste to be transported by a common carrier in order to reduce costs for handling AB 45 (Mullin) Page 23 of ? expired pharmaceutical wastes. SB 966 (Simitian/Kuehl, Chapter 542, Statutes of 2007) requires the Integrated Waste Management Board to identify and develop model programs for the safe disposal of household generated pharmaceutical waste. AB 2335 (Saldana, Chapter 166, Statutes of 2006) makes various clarifying changes to the MWMA with the aim of reducing medical waste management costs and clarifying the complex regulatory framework. SB 1305 (Figueroa, Chapter 64, Statutes of 2006) prohibits a person from knowingly placing home-generated sharps waste in the commercial and residential solid waste collection containers after September 1, 2008. SB 1362 (Figueroa, Chapter 157, Statutes of 2004) allows a household hazardous waste collection facility to operate as a home-generated sharps consolidation point if certain conditions are met. The bill also allows a city or county HHW Element to collect, treat, and dispose of household sharps. SB 407 (Alpert, Chapter 139, Statutes of 1999) authorizes the use of chemical disinfection as a treatment method for certain types of laboratory-generated medical waste if specified requirements were met. SB 1966 (Wright, Chapter 536, Statutes of 1996) moved the management and handling of waste pharmaceuticals under DPH and the MWMA and reestablished fee authorities for DPH for small quantity medical waste generators. SB 372 (Wright, Chapter 877, Statutes of 1995) makes various changes to the MWMA, including revisions to the definition of large quantity generator, medical waste exclusions, and storage. The bill also incorporated additional classes into the definition of medical waste and authorized the use of high temperatures to treat medical waste prior to disposal. SB 1360 (Committee on Health and Human Services, Chapter 415, Statutes of 1995) moved the MWMA to the DPH during Governor Wilson's reorganization of the Department of Health Services to DPH and the California Environmental Protection Agency. AB 45 (Mullin) Page 24 of ? SOURCE: Author SUPPORT: Advanced Medical Technology Association (AdvaMed) Biocom California Life Science Association California Pharmacists Association California Retailers Association Consumer Healthcare Products Association Generic Pharmaceutical Association National Association of Chain Drug Stores OPPOSE: Alameda County Board of Supervisors Alameda County Hazardous Materials Facility Alameda County Meds Coalition Alameda StopWaste Butte County Board of Supervisors California Association of Environmental Health Administrators California Association of Retired Americans California Environmental Health Directors California Hepatitis C Task Force California League of Conservation Voters California Product Stewardship Council California Refuse Recycling Council California Resource Recovery Association California State Association of Counties Californian's Against Waste City and County of San Francisco City of Burbank City of Camarillo City of Chula Vista City of Claremont City of Clovis City of Commerce City of Culver City City of Cupertino City of Diamond Bar City of Lakewood City of Mountain View City of Palo Alto AB 45 (Mullin) Page 25 of ? City of Pasadena City of Roseville City of Santa Monica City of Stockton City of Sunnyvale City of Thousand Oaks City of Torrance City of West Hollywood Clean Water Action Contra Costa County Board of Supervisors County of Sacramento Del Norte Solid Waste Management Authority Delta Diablo Goodwill Industries of San Francisco, San Mateo, and Marin Green Sangha of Marin Health Officers Association of California Hope2gether Foundation Kern County Board of Supervisors Kern County Public Works Department League of California Cities League of Women Voters of California Los Angeles County Board of Supervisors Los Angeles County Department of Public Works Los Angeles County Solid Waste Management Committee/Integrated Waste Management Task Force Marin County Board of Supervisors Marin County Pharmacist Association Marin Household Hazardous Waste Facility Marin Sanitary Service Mojave Desert and Mountain Recycling Authority Napa County Board of Supervisors Napa Recycling and Waste Services Napa Sanitation District Napa Upper Valley Waste Management Agency National Association of Hazardous Materials Managers, California Chapter and National Coalition Against Prescription Drug Abuse Peninsula Sanitary Service, Inc. Pharmacy Defense Fund Pharmacy Planning Service, Inc. Planning and Conservation League Recology Riverside County Department of Waste Resources AB 45 (Mullin) Page 26 of ? Rural County Representatives of California Russian River Watershed Association Salinas Valley Recycles San Joaquin County Public Works San Luis Obispo County Integrated Waste Management Authority Sanitation Districts of Los Angeles County Santa Barbara County Santa Barbara County Board of Supervisors Santa Clara County Board of Supervisors Santa Clara County, Recycling and Waste Reduction Commission Santa Cruz County Board of Supervisors Santa Monica Mayor Tony Vazquez Seventh Generation Advisors Sierra Club California Solano County Board of Supervisors Solid Waste Association of North America Solid Waste Solutions, Inc. Sonoma County Board of Supervisors Sonoma County Waste Management Agency Sonoma County Water Agency Stanislaus County StopWaste Surfrider Foundation Teamsters Local 396 Tulare County Board of Supervisors Upper Valley Waste Management Agency Urban Counties of California Waterkeeper Western Placer Waste Management Authority Yolo County Board of Supervisors Zero Waste Marin ARGUMENTS IN SUPPORT: Supporters believe that "it is critical that dialogue continues on HHW disposal. AB 45 is a critical piece of that conversation, and its continued progress will allow those conversations to continue within the framework and sense of urgency that active legislation creates." ARGUMENTS IN OPPOSITION: Local jurisdictions throughout the state strongly oppose AB 45. Dozens of letters from various sizes and types of jurisdictions AB 45 (Mullin) Page 27 of ? have been submitted to the committee which outline the successful collection of hundreds of thousands of pounds of HHW, pharmaceutical waste and sharps waste within those jurisdictions. What appears as a constant frustration, is the lack of resources to do more. "Local jurisdictions have historically been authorized to develop and implement HHW collection, recycling, and educational programs which reflect local needs. AB 45 would instead create a one-size-fits-all approach which may not reflect local conditions and would do little to support efforts to reduce HHW generation. AB 45 would discourage and undermine efforts by local governments to implement extended producer responsibility (EPR) programs for uniquely problematic wastes, such as HHW, pharmaceutical waste, and sharps waste. Many jurisdictions in California have adopted pharmaceutical take-back ordinances, and our Board is considering the adoption of a pharmaceutical and sharps waste EPR ordinance, in which manufacturers would provide safe, convenient and sustainably financed take-back programs for their products at the end of their useful life. AB 45 does not provide a source of funding to sustainably collect and process waste, and limits the industry's role in managing HHW to outreach only, which is contrary to Los Angeles County's support for EPR policies that place shared responsibility for end-of-life product management on all entities involved in a product chain, including producers." --- END ---