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California State Auditor Report Number : 2016-127

Home‑Generated Sharps and Pharmaceutical Waste
By Designating a Lead Agency, the State Could Increase Proper Disposal



Every year Californians use hundreds of millions of sharps—such as syringes, lancets, and other devices used to penetrate the skin for the delivery of medications—and obtain hundreds of millions of prescriptions, according to estimates by the California Department of Resources Recycling and Recovery (CalRecycle) and by the Henry J. Kaiser Family Foundation, a nonprofit organization. When consumers improperly dispose of these sharps and pharmaceuticals, the discarded items can potentially pose health, safety, and environmental risks.

Agencies That Have Responsibilities Related to Home‑Generated Sharps and Pharmaceutical Waste

California Department of Public Health (Public Health): Regulates medical waste management programs, which encompass home‑generated sharps when consolidated as medical waste.

CalRecycle: Collects information on the amount of household hazardous waste consumers dispose of, which includes home‑generated sharps and pharmaceuticals.

California State Board of Pharmacy (Pharmacy Board): Licenses pharmacies, which serve as collection sites for home‑generated sharps and pharmaceutical waste.

Department of Toxic Substances Control (Toxic Substances Control): Issues permits for household hazardous waste sites, which consumers can use to dispose of sharps and pharmaceuticals.

Source: State law, Public Health staff, and CalRecycle’s website.

If residents improperly dispose of home‑generated sharps waste, that waste can represent a risk to public health. For example, if consumers dispose of sharps waste through the trash, workers who process that trash may be stuck by loose needles. A 2015 report by the University of California, Berkeley, for the Commission on Health and Safety and Workers’ Compensation indicated that the risk of contracting serious diseases, such as HIV, from such injuries is low. However, because of the fear of disease contraction, needle‑stick injuries can result in significant psychological stress, if not infection.

On the other hand, the risks associated with the improper disposal of pharmaceutical waste largely relate to environmental impact and inappropriate consumption. Pharmaceutical waste consists of both prescription and over‑the‑counter medications. In a 2011 study, the U.S. Geological Survey found that measurable amounts of pharmaceutical compounds were present in the State’s groundwater. These compounds can come from a number of different sources, including treated wastewater, landfills, septic systems, sewer lines, and animal waste. Pharmaceutical waste in waterways can cause behavioral changes in fish, according to a 2014 study published by the Royal Society, a scientific academy. A separate danger is that minors or opioid addicts may consume unused pharmaceuticals that consumers stockpile in homes or dispose of improperly.

Four state agencies are involved in overseeing or regulating the disposal of home‑generated sharps and pharmaceutical waste. The text box contains short descriptions of the agencies and their regulatory responsibilities related to these types of waste.

The Disposal and Treatment of Home‑Generated Sharps Waste

State Law Allows Four Types of Facilities to Collect Home‑Generated Sharps Waste

Household hazardous waste sites: These facilities may be operated by local government entities and collect a wide variety of hazardous waste, including paint and motor oil.

Consolidation points for home‑generated sharps: Consolidation points must be approved by Public Health or other local enforcement agencies, and they can be pharmacies, police departments, or other facilities.

Medical waste generators: Businesses that generate medical waste include hospitals and clinics.

Facilities that receive sharps through mail‑back containers: Generally, private waste management and medical device companies are vendors for mail‑back containers, which are required to be approved by the U.S. Postal Service.

Source: State law, Public Health staff, and CalRecycle’s website.

California law imposes a number of restrictions on the disposal of home‑generated sharps. The Medical Waste Management Act (medical waste act), enacted in 1995, regulates the disposal of medical waste in California from commercial sources, such as hospitals, clinics, and other medical waste generators. Although the medical waste act specifically excludes home‑generated waste from its requirements, it also states that collection sites must treat any home‑generated sharps waste they receive as medical waste. Further, since September 2008, state law has specifically prohibited California residents from disposing of sharps waste in the trash.

Both Public Health and CalRecycle encourage consumers to dispose of their sharps waste at collection sites or via approved mail‑back containers. State law limits collection of home‑generated sharps waste to the entities listed in the text box. As Figure 1 shows, approved collection sites can include pharmacies, hospitals, household hazardous waste sites, police stations, or sharps collection kiosks. State law requires that when residents return sharps waste to collection sites, they do so in approved sharps containers or other containers that local enforcement agencies may approve. In addition, consumers may purchase or otherwise obtain U.S. Postal Service‑approved mail‑back containers to dispose of sharps waste by mailing it to disposal facilities. Finally, local governments may provide a collection service through waste haulers. This service allows consumers to call their local trash haulers to request sharps collection at their residences.

Figure 1
Collection Sites Offer Options for Legal Disposal of Home‑Generated Sharps

 Figure 1 shows options for the legal and illegal disposal of home-generated sharps, selected collection sites, and how legally disposed of sharps are processed.

Sources: California State Auditor’s analysis of relevant laws pertaining to home‑generated sharps disposal, information from Public Health as well as sharps disposal information from programs in San Luis Obispo County, Orange County, and the City and County of San Francisco.

The type of collection site at which consumers dispose of sharps waste will determine how the waste is processed. Because state law requires collection sites to dispose of sharps as medical waste, the sites must send sharps waste to approved medical waste treatment facilities for treatment and disposal. There are 18 medical waste treatment facilities that operate in California. These treatment facilities can sterilize sharps waste to protect against disease transmission, and then they may dispose of the waste in landfills. However, federal law imposes different requirements when consumers return sharps waste to household hazardous waste sites. Specifically, even though sharps waste may not be considered hazardous waste legally, federal law states that any mixture of solid waste and hazardous waste is a hazardous waste.

The Disposal and Treatment of Home‑Generated Pharmaceutical Waste

Although state law defines pharmaceutical waste, it does not identify or provide any specific regulatory framework for home‑generated pharmaceutical waste. As household waste, home‑generated pharmaceutical waste—in most circumstances— is exempt from state and federal hazardous waste laws and state medical waste laws. Thus, consumers may legally dispose of their pharmaceutical waste in their garbage. However, federal regulations do place certain restrictions on the collection of pharmaceutical waste that contains controlled substances. Specifically, federal law mandates that controlled substances can only be collected by law enforcement and certain collection sites that register with the Drug Enforcement Administration (DEA), such as hospitals and pharmacies.

Californians have several options for legally disposing of most pharmaceutical waste; however, not all of the methods are equally safe and appropriate. For example, California law does not clearly prohibit consumers from disposing of pharmaceutical waste by placing it in the trash or by flushing it down the toilet. However, localities may prohibit the flushing of home‑generated pharmaceutical waste, as does the City and County of San Francisco (San Francisco), citing concerns with water quality. For the same reason, state agencies discourage the practice. Figure 2 shows that the methods consumers use to dispose of pharmaceutical waste determine the state and federal agencies with oversight authority of that waste.

Figure 2
California’s Consumers Unknowingly Choose How Home‑Generated Pharmaceutical Waste Is Processed

Figure 2 is a flow chart that shows that consumers’ choice of where they dispose of their pharmaceutical waste impacts how that waste is disposed and what agencies regulate that disposal.

Source: Federal and state law, interviews with agency staff, and pharmaceutical collection programs in San Luis Obispo County and in San Francisco.

* Reverse distributors act as agents for pharmacies and other entities by receiving, inventorying, managing, and disposing of outdated or unsalable dangerous drugs. DEA regulations require reverse distributors to either render controlled substances irretrievable or return them to the manufacturer.

In 2010 CalRecycle issued a report outlining its adopted model guidelines for home‑generated pharmaceutical collection programs. Its guidelines recommended that programs allow residents to return pharmaceutical waste to designated permanent collection sites, which can include pharmacies, health care collection sites, police stations, and public health agencies, among others. Also, consumers may use approved mail‑back containers to send pharmaceuticals to registered collectors of controlled substances.

CalRecycle’s model guidelines recommend that collection sites should treat home‑generated pharmaceutical waste as either medical or hazardous waste. Additionally, in 2012 the U.S. Environmental Protection Agency (EPA) recommended that collection sites destroy pharmaceutical waste using hazardous waste incinerators or, if these are not feasible, municipal waste incinerators. As we discuss in the Audit Results, local data suggest that most incineration of pharmaceutical waste occurs out of state, although California’s in‑state incinerators can and do destroy some amount of pharmaceutical waste. Figure 3 illustrates the different recommendations that federal and state agencies have issued for how to dispose of sharps and pharmaceutical waste other than controlled substances.

Figure 3
State and Federal Agencies Suggest Ways to Dispose of Home‑Generated Sharps and Pharmaceutical Waste

Figure 3 is a graphic that demonstrates some of the different ways state and federal agencies tell consumers to dispose of home-generated sharps and pharmaceutical waste.

Source: California State Auditor’s analysis of federal and state agencies’ messages about proper disposal of home‑generated sharps and pharmaceutical waste.

Scope and Methodology

The Joint Legislative Audit Committee (Audit Committee) directed the California State Auditor to conduct an audit of home‑generated sharps and pharmaceutical waste disposal in California. We list in Table 1 the Audit Committee’s 11 separate approved objectives and the methods we used to address them.

Table 1
Audit Objectives and the Methods We Used to Address Them
  Audit Objective Method
1 Review and evaluate the laws, rules, and regulations significant to the audit objectives. Reviewed relevant laws, rules, and regulations related to Public Health, CalRecycle, the Pharmacy Board, and Toxic Substances Control.
2 To the extent that home‑generated medical waste information is available, do the following:  
a. Determine, to the extent possible, the volume of home‑generated sharps and pharmaceutical waste that was disposed of statewide using approved household disposal methods over the past three years.
  • Searched pertinent websites to determine what data exist for the volume of home‑generated sharps and pharmaceutical waste properly disposed of from fiscal years 2013–14 through 2015–16.

  • Obtained and tested household hazardous waste site collection data to determine the extent of data inaccuracies. We determined whether we could use any of the data to estimate statewide sharps and pharmaceutical waste volume.

  • Developed an annual statewide estimate based on data from San Francisco, as well as from other sources, because San Francisco’s large population makes its data less variable than those of cities or counties with smaller populations, and because it has multiple data sources.
b. Estimate, to the extent possible, the volume of home‑generated sharps and pharmaceutical waste that may have been improperly disposed of statewide over the past three years. Searched pertinent websites to determine what data exist for the volume of home‑generated sharps and pharmaceutical waste improperly disposed of from fiscal years 2013–14 through 2015–16.
c. Assess, to the extent possible, differences in home‑generated sharps and pharmaceutical waste in areas with needle exchange programs versus areas without such programs. Reviewed syringe exchange program data from 11 syringe exchange programs, as well as from two of the counties we visited. Because these programs collect data inconsistently, we were unable to assess for collection differences.
3 Identify the methods that exist currently for free home‑generated sharps and pharmaceutical waste disposal within California. Obtained and reviewed lists that contain information regarding free home‑generated sharps and pharmaceutical waste collection sites and determined the accuracy of these lists. We also used geographic information systems software to compare the availability of home‑generated sharps and pharmaceutical waste collection sites to U.S. Census data for California.
4 To the extent that information is available, determine the collection rate for voluntary take‑back programs that manufacturers funded in the past three years for home‑generated sharps and pharmaceutical waste. Determined whether manufacturer‑funded take‑back programs existed within each jurisdiction we visited.Reviewed qualities and implementation of extended producer responsibility programs and ordinances in San Francisco and in Alameda County.
5 Determine which medical waste collection models generate the best waste‑collection results for both home‑generated sharps and pharmaceutical waste. Consider county‑based collection models, including needle exchange programs, as well as those adopted in Canada and other countries. Performed online research on three states and four countries to understand their home‑generated pharmaceutical and sharps collection models and data. In addition, we evaluated county‑based collection models in San Francisco and in San Luis Obispo County. Because of these programs’ data limitations, we were unable to compare the effectiveness of their efforts.
6 Identify any existing regulatory limitations on establishing home‑generated sharps or pharmaceutical waste collection sites or on methods for collecting that waste. Assess the reasonableness of any barriers that exist. Identified limitations caused by legal requirements for various collection types. Reviewed the legal impact of classifying home‑generated pharmaceutical waste as hazardous waste.
7     To the extent that information related to waste‑processing capacity is available, do the following:  
a. Determine the statewide capacity for processing home‑generated sharps and pharmaceutical waste in each of the last three years. Calculated the statewide capacity available for medical waste treatment and determined the statewide capacity for incineration.
b. Determine the existing waste‑processing capacity in California that could accommodate growth in proper disposal of home‑generated sharps and, if applicable,  of pharmaceutical waste. Calculated the existing statewide processing capacity to accommodate both sharps and pharmaceutical waste disposal and compared total available capacity to our estimate of current sharps and pharmaceutical waste collection.
8 Determine where home‑generated sharps and pharmaceutical waste is processed and the methods used to process the waste.
  • Determined methods with which California home‑generated sharps and pharmaceuticals is treated and processed and where this information is documented.

  • Analyzed local tracking documents, medical waste treatment permits, and waste‑to‑energy facility reports to determine how medical waste is processed in California, and where waste goes after it is treated.
9 To the extent possible, compare processing rates for home‑generated sharps and, if applicable, home‑generated pharmaceutical waste, in a selection of jurisdictions Public Health oversees to a comparable selection of jurisdictions with local oversight. Determine what differences exist among the jurisdictions that may affect California’s processing rates. Obtained processing rates for home‑generated sharps and home‑generated pharmaceutical waste, for the three counties we visited, of which one, San Luis Obispo, was under Public Health’s oversight. However, because of differences in data collection methods, we were unable to compare their efforts.
10 Identify the recommendations CalRecycle and Public Health have made regarding home‑generated sharps and pharmaceutical waste collection and disposal. Assess whether the recommendations reflect best practices.
  • Reviewed CalRecycle’s 2010 Report to the Legislature—Recommendations for Home‑Generated Pharmaceutical Collection Programs in California (recommendations report).

  • Assessed the feasibility of the options CalRecycle identified in the report based on four criteria specified in state law: safety, accessibility, cost‑effectiveness, and efficacy.
11 Review and assess any other issues that are significant to the audit.
  • Reviewed federal and state entities websites for messages to consumers regarding the disposal of home‑generated sharps and pharmaceutical waste.

  • Analyzed messages to identify trends and conflicts.
Source: California State Auditor’s analysis of the Audit Committee’s audit request number 2016‑127, state law, planning documents, and analysis of information and documentation identified in the column titled Method.

Assessment of Data Reliability

The U.S. Government Accountability Office (GAO), whose standards we are statutorily required to follow, requires us to assess the sufficiency and appropriateness of the computer‑processed information that we use to support our findings, conclusions, or recommendations. Table 2 describes the analyses we conducted using the data from the information systems we used, our methods for testing them, and the results of our assessments.

Table 2
Methods Used to Assess Data Reliability
Information System Purpose Method and Result Conclusion

CalRecycle’s Facility Information Toolbox (FacIT)

Public Health list of consolidation sites

Pharmacy Board list of active pharmacies

DEA online search locator

Walgreen Co.’s (Walgreens)  pharmacy list

To develop a combined list of free home-generated sharps and pharmaceutical waste collection sites for our analysis of access in California.

To test the completeness of combined list, we compared the pharmacies on these lists to the Pharmacy Board’s list of active pharmacies and identified several errors, which we corrected.

To test the accuracy of the information, we contacted a random sample of collection sites from the combined list and identified several inconsistencies, which we corrected.

Not sufficiently reliable for the purpose of this audit. Although this determination may affect the precision and completeness of the collection site locations we present, there is sufficient evidence in total to support our findings, conclusions, and recommendations.

CalRecycle’s Form 303 reporting file

To accurately determine the volume of home-generated sharps and pharmaceutical waste collected at household hazardous waste sites.

To test the accuracy and completeness of this data we analyzed the data and identified missing entries, reporting inconsistencies, and other obvious errors.

Not sufficiently reliable for the purpose of this audit. Although this determination may affect the precision of the numbers we present, there is sufficient evidence in total to support our findings, conclusions, and recommendations.

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